Overview of salaries statistics of the profession "Clinical Associate in Munster"
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Overview of salaries statistics of the profession "Clinical Associate in Munster"
3 134 £ Average monthly salary
Average salary in the last 12 months: "Clinical Associate in Munster"
The bar chart shows the change in the level of average salary of the profession Clinical Associate in Munster.
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Among similar professions in Munster the highest-paid are considered to be Haematologist. According to our website the average salary is 10129 GBP. In the second place is Physician with a salary 9991 GBP, and the third - Dentist with a salary 6010 GBP.
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Clinical Publisher Associate
, Cork, County Cork, Republic of
Purpose:The purpose of the Central Regulatory Registration (CRR) Associate role is to manage a portfolio of molecules/products for global regulatory registrations in major markets across the products’ lifecycle from candidate selection through product withdrawal. This person will have the responsibility to create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. The Associate collaborates with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines. The Associate is expected to provide business process knowledge and leadership to customers to resolve publishing issues and drive on time submissions The Associate also works closely with Regulatory Associates and Regulatory Scientists to manage information from regulatory agency interactions to ensure appropriate tracking of project timelines, pending approvals, and commitments. The Associates work involves technical, cross-functional processes in an environment of critical time frames and potentially changing priorities, therefore, a strong emphasis is placed on teamwork, leadership, communication, and self-management..Primary Responsibilities:Functional and Technical Expertise * Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management. * Demonstrate in-depth understanding of ICH CTD format/style requirements and evolving US/OUS agency standards/trends. Apply knowledge to manage a variety of complex submissions * Provide publishing to influence strategies of upstream contributors/vendors to enable successful implementation with minimal impact to resources and supply chain. * Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labeling to deliver the submission. * Understand, log, and manage Incoming Correspondence from and all Records of Contact with the FDA to enable rapid and accurate updates to RAPT and RCTT impacting project timelines and pending approvals. * Accountable as process owner of a specific process. (e.g., ROCs/IC, RAPT eFiles, Publisher Qualification, CRF/CRT, OUS Submissions, etc.) to technically evaluate, drive improvements and contribute to RQS procedures. * Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway to ensure compliance. Stay up to date on system and tool upgrades. * Demonstrate in-depth understanding of complex multiple FDA forms and apply project knowledge to ensure accurate submissions. * Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission. * Coordinate with RACMC Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct. * Leverages internal and external forums to continue to develop and share regulatory and drug development expertise around electronic submission structure and content.Decision Making * Make decisions based on ICH guidance and global regulations to ensure compliant submissions and to drive improvements. * Identify errors in documents from contributing authors/vendors and initiates resolution of issues/errors/discrepancies. * Participate in and understand the goals of the regulatory publishing strategies of assigned molecules. * Use molecule/product and registration knowledge to accurately assign keywords, and accurately populate/execute complex FDA Forms.Influence * Educate and influence cross-functional DCoE, Sci Com, and Labeling consultants on submission requirements for CRFs, datasets, literature references, and labeling, to ensure alignment and reduce potential technical issues impacting submission timelines. * Lead the coordination with other publishing centres and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy. * Drive improvement in SME area with registration process owner and management and incorporates changes to job aids, Publisher Qualification program, and RQS procedures. * Influence Regulatory Scientists and/or Directors to complete and sign cover letters and forms in critical timelines to ensure on time submissions. * Drive process and influence Regulatory Associates and cross-functional partners (CMC Director) to review RAPT reports and update status of US applications per required timelines. * Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.Problem SolvingIdentify gaps and define needs to optimize publishing processes/tools that meet agency preferred specifications and CRR submission work, identify molecule specific eCTDXpress publishing errors/issues and influence Regulatory Associates/authors/vendors/consultants to correct errors and coach to build capability for future submissions, trouble shoot compile issues and proactively collaborate cross-functionally to resolve, test new software updates and identify/report issues impacting publishing, partner with quality to help determine root cause analysis of deviations.ImpactFacilitate efficient review of the registration by the regulatory agency, ensure compliance submissions are delivered on time, positively impact regulatory cross-functional initiatives through active participation in process improvement projects, drafting/reviewing RQS documents, develop procedures and Job Aids for SME area, initiates consultation with Regulatory Associates and Regulatory Scientists to share best practices and move towards more efficient/effective work processes, perform quality review of peer’s submissions to ensure accuracy/compliance and coach to improve, train new Submission Publishers.Project ManagementConduct submission planning for assigned portfolio by identifying publishing milestone requirements for upcoming submissions and planning/managing workload to ensure on time submissions, proactively seeking resources when needed, lead troubleshooting investigations for compile issues for assigned molecules, coordinate and communicates with Regulatory Associates to prepare for unique requirements for the molecules and plan for upcoming submissions, proactively review multiple document sites to assess timing of document readiness from upstream authors and work ahead to publish documents, serve as a single point of contact for customers (e.g., Regulatory Associates, Regulatory Scientists, authors, cross functional stakeholders) for managing the submissions in eCTDXpress backbone, identify, escalate, and resolve issues that may impact submissions.Customer FocusCollaborate with Regulatory Associate for submission bundling opportunities, partner with other geographies to identify, understand, and incorporate EU and OUS agency regulations and county specific requirements to effectively influence the electronic registration plan, develop collaborative relationships with personnel in other functional areas (e.g. DCoE/medical, RACMC, GOLD, Quality etc.).Minimum Qualification Requirements:The following skills and abilities are directly related to the essential functions of the job. * Degree qualified in a related field * 3 years’ experience publishing submissions using eCTDXpress. * Demonstrated project management and time management skills. * Demonstrated organization and priority setting skills: must be able to manage diverse tasks and processes. * High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases. * Proficiency in SharePoint technology
CMC Regulatory Associate
, Cork, County Cork, Republic of
CMC DepartmentGRA - Chemistry, Manufacturing, and Control (CMC) is responsible for regulatory strategy, submissions and regulator interactions associated with all products in development up to and including initial market applications in all countries around the globe. GRA-CMC is also responsible for the regulatory strategy and post approval submissions for Commercial Products to ensure reliable supply and continuous improvements. This includes small molecules, biotechnology, Insulin products, devices, and drug / device combination products.They work in collaboration with other areas of GRA, Product Research & Development, Technical Services / Manufacturing Sciences, Quality, Product Delivery PM, PPM, and PDS to develop CMC regulatory strategies, provide regulatory risk assessments, and implement regulatory processes to support products and CMC teams.VisionTo be Industry Leading in Application of CMC Regulatory Science, Leveraging Quality by Design to Obtain Timely Approvals that Enable Continuous Improvements in Product Quality and Manufacturing Processes.The roleMy client is looking for an associate to lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. This exciting opportunity will enable you to utilize your project management and communication skills to advance the submission process for new molecules. You will also partner with GRA-CMC Scientists to help build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission related Ministry of Health responses or our client’s affiliate questions. You will work within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working understanding of internal procedures, guidances and regulatory precedence. You will triage and lead the communications between our client’s Affiliates, GRA-CMC Scientists, and Specialists. You will be the point person for communication regarding submission tracking requirements to both GRA-CMC Scientists and internal customers.Regulatory & Drug Development Expertise * Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. * Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements. * Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. * Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions. * Responsible for triage of our client’s affiliate inquires and requests and when necessary consults with CMC RA Scientist for guidance in effort to prepare responses to questions. * Implement and in some cases interpret global regulations and guidances and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with our client affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.Lead, Influence, Partner * Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues. * Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements. * Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes * Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographiesBasic Qualifications * Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)Knowledge of pharmaceutical drug development or industry-related experience preferred
CMC Development Regulatory Associate
, Cork, County Cork, Republic of
Purpose:The purpose of the CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate leads the operational and technical aspects of clinical trial and global marketing authorization submissions for the small and large molecule portfolios in partnership with the Global Regulatory Affairs CMC Regulatory Scientists. The Regulatory Associate partners with the GRA-CMC Scientists to create and manage submission documents and provides guidance on structure and content placement. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.This is accomplished by a strong working knowledge of customers, internal procedures, regulatory guidance and precedence. The Regulatory Associate triages and manages communications between mi client’s global Affiliates, GRA-CMC Scientists, CMC teams, Clinical teams, and Quality/Regulatory Representatives. The Regulatory Associate utilizes submission process expertise to facilitate project management expectations across projects. The scope of work includes global regulatory requirement assessment and understanding strategy development in relation to submission management.Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Regulatory & Drug Development Expertise * Partner with the CMC Regulatory Scientists to drive the execution of submission planning for clinical trials and global registration submissions. This includes defining key requirements for individual countries and managing questions from affiliates and agencies, establishing and monitoring content due dates, and executing the integrated regulatory strategy to ensure timely submissions. * Review regulatory strategies across molecules and identify opportunities to simplify and streamline submissions for markets and/or regions. * Interpret and implement global agency regulations, guidance and regulatory precedence into submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements. * Lead CMC submission management process by providing expertise on internal processes, electronic submission regulations and guidance regarding technical content and structure requirements. * Own the submission management process at the molecule/project submission level to ensure all required electronic records are timely, complete, and accurate. * Serve as the CMC operational lead for global clinical trial applications and registration planning and execution, including critical chain status updates. Own execution of the right to operate routine compliance submissions, such as CMC annual reports (i.e. DSURs). * Understand and support the regulatory processes that enable review and release of clinical trial materials. * Manage CMC databases and/or information tools, prepare periodic or special request submission metrics reports to enable CMC staff to identify and address global agency trends.Lead, Influence, Partner * Lead CMC submission management processes by leveraging expertise to optimize internal processes and tools. Anticipate and resolve process and/or timeline issues. * Develop collegial and mutually productive relationships across my client’s components, partner companies, Affiliates and regulatory submission centres that enable a team environment of developing quality submissions in a timely fashion. * Partner with the Regulatory Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions. * Lead communication and transfer of registration submission commitments between GRA-CMC and Site Regulatory Affairs groups. * Create an environment within Global Regulatory Affairs and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues. * Leverage internal and external forums to develop and share regulatory and drug development expertise around electronic submission structure and content. * Communicate verbally and in writing to effectively influence within the GRA function and development teams. * Guide and influence development teams and functions regarding internal and Agency life-cycle management processes and requirements. * Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues. * Proactive in approaching higher level colleagues in various organizations.Business ExpertiseSubject matter expert (SME) responsible for the technical evaluation, implementation and documentation of CMC regulatory content, submission procedures/guidance, submission integration, and submission tracking, comprehensive knowledge of evolving global agency publishing standards, comprehensive knowledge and skills related to the systems, processes and standards, demonstrate expertise at planning CMC submissions.Minimum Qualification Requirements: * * Industry-related experience * Knowledge of drug development process * Demonstrated ability to manage operational requirements in a regulated environment * Demonstrated written, spoken, and presentation communication * Demonstrated negotiation and influence skills * Demonstrated attention to detail * Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities * Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles * Education: Combination of industry/regulatory business and/or technical knowledge and skills developed through education and experience
Clinical Regulatory Associate
, Cork, County Cork, Republic of
Purpose:The purpose of this role is to manage the accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across our client’s components, partner companies, and within relevant ministries of health. The successful candidate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency, and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embrace corporate transformation initiatives and represent Global Regulatory Affairs-NA (GRA-NA) as a change ambassadorProvide Regulatory & Drug Development Expertise * Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for GRA-NA. This includes but us not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD. * Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification * Guide and influence development team and function regarding internal and Agency registration management processes and requirements * Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate Records include: The IND and NDA submissions, Tracking the status of pending applications and commitment, Incoming correspondence and records of contact * Serve as the GRA-NA operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRACRR planning. * Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions. * Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process * Provide registration management expertise to the due diligence and business development processes. * Serve as the registration management expert for other processes dependent upon the registration record * (e.g. OSI requests, out-license, user fees/drug listing/orange book)Lead/Influence/Partner * Develop collaborative relationships with personnel in other functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan. * Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions. * Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review * Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings. * Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise. * Influence others in a manner that creates maximum advantage for the organization. * Communicate verbally and in writing to effectively influence within work group/function and with development team * Serve as a mentor within GRA.Minimum Qualification Requirements: * A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.Other Information/Additional Preferences: * Industry-related experience * Knowledge of drug development process, regulatory/business strategies and plans * Demonstrated ability operate and manage operational requirements in a highly regulated environment * Demonstrated effective written, spoken and presentation communication * Demonstrated effective negotiation and influence skills * Demonstrated attention to detail * Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Global Scientific Communications Associate - Publications
, Cork, County Cork, Republic of
Qualifications: * Bachelor’s degree in a scientific, health, communications, health outcomes, health economics, public health related field * Experience writing scientific publications. * Strong communication and interpersonal skills. * Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)Additional Information :The purpose of the Scientific Communications Associate, Publications role is to work with cross-functional, multidisciplinary teams to prepare scientific publications (clinical and/or health-outcomes) including and not limited to, abstracts, posters, manuscripts and presentations.Travel Percentage:0-10%Responsibilities:Content Strategy: Document Preparation, Development and Finalization/Document Management * Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. * Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review coordinate and complete the publication of scientific data in peer-reviewed journals and forums. * Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding. * Build scientific-based rational that support the purpose of more complex and/or strategic documents. * Ensure data are presented in a clear, complete, accurate, and concise manner. * Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. * Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version. * Ensure and coordinate quality checks for accuracy, * Exhibit flexibility in moving across development and preparation of multiple document types. * Influence or negotiate change of timelines and content with other team members. * Advocate internally and externally for appropriate authorship criteria on all applicable work products. * Work with internal and external speakers to develop and prepare presentations. * As needed, build and manage relationships with vendors/alliance partners.Project and Stakeholder management * Lead the writing process and apply effective project management skills to ensure timely completion of high-quality scientific publication deliverables. * Build/Communicate credible writing project timelines. * Anticipate and mitigate risks to delivery * Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. * Effectively communicate project status to stakeholdersKnowledge and Skills Development * Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). * Maintain and enhance scientific communication skills to align with audience needs and technology/digital evolution. * Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. * Maintain and enhance knowledge of publication guidelines. * Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in publication planning, integrated planning process, and/or current awareness literature updates and reviews.Knowledge Sharing * Provide coaching to others by sharing technical information, giving guidance, answering questions, Recognized for technical expertise in specific document development, Network with others (including other functions and regions) to identify and share best practices, Contribute to process improvements, suggesting opportunities where appropriate, Provide database and other tool (e.g., document management systems) expertise.Additional Skills/Preferences: * Advanced degree (PhD, MD, PharmD, MA, MBBS) in science, health related field or other appropriate disciplines (economics, epidemiology, health administration, health services, pharmacoeconomics, statistics other relevant sciences), Demonstrated mastery of verbal and written English skills in the medical, scientific, health outcomes, or technical writing fields, Previous training and experience in disseminating results in clinical, health economics, health outcomes, health literacy, disease management, and/or population health, Relevant experience in clinical development, clinical trial process, health-outcomes research, or regulatory activities, Clinical pharmacology, therapeutic area, health outcomes, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise), Demonstrated project management and time management skills, Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates), Extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically, Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills
Clinical Trial Associate - Italian
, Cork, County Cork, Republic of
About company: * Our client is a global leading pharmaceutical company who are searching for a Clinical Trial Associate to join a brand new exciting project. * The Clinical Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training. * The Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.Responsibilities: * Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities * Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out * Identify, communicate, and resolve issues * Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems * Leverage previous site / review board engagements to efficiently drive new work * Populate internal systems to ensure accuracy of trial / site performance * Understand and comply with procurements, legal, financial requirements and procedures * Populate Trial Master Files and libraries for future reference * Provide feedback and shared learning for continuous improvement * Leverage trial prioritization * Anticipate and monitor dynamically changing prioritiesBasic Qualifications: * Bachelor’s degree preferably in a scientific or health related field * 2 years clinical research experience or relevant experience preferred * Fluency in both English and Italian * Understanding of overall clinical development paradigm and the importance of efficient site initiation * Applied knowledge of project management processes and skills * Appreciation of / experience in compliance-driven environment * Ability to learn and comply with financial and legal guidelines and policies (budget and contract)Additional Skills/Preferences: * Effective communication, negotiation, and problem solving skills * Fluent in another language (Hungarian, Nordic, Spanish, French, German, Portuguese, etc.)
Associate Director/Director Inspection Management
Morgan McKinley, Limerick, ie
An Associate Director/Director is required to lead Inspection Management in a global Biopharmaceutical company based in Limerick. This stand alone role sits on a Global team and reports directly to the Executive Director of Quality. This individual will provide support during regulatory inspections and internal audits. The successful candidate will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.The role can be broken down into Inspection Readiness and Execution. A typical day in each area might include the following:Inspection Readiness:Benchmark leading practices and recommend improvements to make the site inspection-ready at all times.Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.Build and implement tools to improve inspection readiness.Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.Work closely with other regulatory compliance teams to close gaps and improve inspection readiness capabilities.Inspection Execution:Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters.Respond to incoming inquiries during inspections and audits and ensure timely and accurate responses.Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.Interfaces with customer/partner quality organizations.Participates on internal committees/teams, as required.Provides advice and direction to other company departments on quality and regulatory issues.RequirementsBA/BS degree in a relevant disciplineAs an Associate Director level you must have at least 10 years of relevant experience and for Director level 12 years of relevant experience. The majority of this experience needs to be within the Biotechnology field. Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Clinical Trial Project Manager Associate
, Cork, County Cork, Republic of
ResponsibilitiesThe Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Project Management and Regional Operational Knowledge· Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:· Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.· Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.· Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.· Budget - Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.· Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator training· Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.· Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).· Manage relationships and serve as a single point of contact and central owner for trial communication to and from the Clinical Development, CDDA, and Third Party Organization (TPOs).· Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).· Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.· Manage TPO qualification process, selection, and oversight.Clinical Trial Process Leadership and Expertise· Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.· Be knowledgeable of the global and regional operating model; coordinate and facilitate geographic and functional input to provide to the study teams.· Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development· Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.· Demonstrate ability to lead and influence in the midst of ambiguity and coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.· Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.· Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.\Scientific Expertise· Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.· Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.· Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.Basic Qualifications:Bachelors or University degree (scientific or health-related field preferred) or an advanced degree.Additional Skills/Preferences· Applied knowledge of project management methodology, processes and tools· Demonstrated ability to work cross-culturally with global colleagues and with TPOs· Ability to influence without authority· Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects· Effective and influential communication, self-management, and organizational skills· Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity· Flexibility to adjust to altered priorities· Clinical trial experience with a strong working knowledge of the clinical research process.· Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS PowerPoint)· Ability to travel periodically
Clinical Trials Associate (Budgets & Contracts) fluent Spanish
, Cork, County Cork, Republic of
Our client is a global healthcare leader based in Cork, Ireland. Their goal is to make a difference for people around the world by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that they do are their talented and motivated professionals, circa 900 of whom are based at their Global Business Solutions centre in Little Island, Cork. There they boast vibrant workforce made up of over 44 nationalities.The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Clinical Trial Start Up Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout.Responsibilities: 1. Contract Negotiations: * communicating and negotiating contracts with the appropriate site, team, or affiliate personnel (communicate on various contract issues, identify relationship-building opportunities, secure site contracts, collect site feedback, and facilitate communication with various personnel, communicate and negotiate more complex contracts) 1. TC Process Improvement and Training: * maintaining and conducting contract-related training (develop and implement training for new contract associates and customers, create, maintain, and distribute contract templates, process documentation, and contract-specific documentation (such as the Legal Guidance Document) as the contract process owner, act as a mentor to the Contract Associates to provide the necessary guidance and knowledge transfer to allow the contract associates to be successful negotiators) * providing clinical trial contract guidance to other business partners (develop process documentation, facilitate quality, speed and value through information sharing, , business partnership, and assurance that all guidance is aligned with company`s policies, clinical processes, and appropriate guidance, serve as the primary contact and process owner for interactions between TC and the Legal personnel related to process changes, documentation requirements, and site contracting issues) 1. Contract Process Improvements: * identifying and implementing improvements to the contracting processes (standardizing and streamlining contract activities, as well as using metrics to drive improvement throughout the entire contracting process, increase contracting efficiency and effectiveness by ensuring that learning is shared and leveraged, anticipate changes by evaluating issues and opportunities, both internal and external, and making recommendations to TC management)Requirements: * Bachelor’s degree in a relevant discipline * 3-5 years of experience negotiating contracts in clinical trials or similar * Native Spanish speaker and fluency in English * Strong organizational/time management skills, analytical skills, negotiation skills, critical thinking skillsOther Information/Additional Preferences: * Advanced degree or legal degree * Thorough understanding of GDPR and other privacy regulations * Experience negotiating privacy clauses with clinical research sites * Experience working with global business partners and a global team