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Staff Clinical Research Project Manager (1432)
Ref No.: 18-27742
Location: West Chester, Pennsylvania
Position Description
Staff Clinical Research Project Manager (Staff Clinical Research Scientist)
Manager (Staff Clinical Research Scientist) will be responsible for the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
The Staff Clinical Research Project Manager (Staff Clinical Research Scientist) will:
¿ Lead the development of Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access).
¿ Ensure input and strong alignment from key regional MD Clinical R&D leads and other strategically important countries/regions in the development of the EGS / EDS.
¿ Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision.
¿ Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures.
¿ Assume responsibility for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostats and Data Management (BSDM) teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP).
¿ Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
¿ Draft study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory submissions.
¿ Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;.

¿ Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, Clinical Study Reports (CSR), and use of clinical data/evidence for market access and reimbursement.
¿ Foster strong relationships with key investigators to deliver evidence.
¿ Ensure study registration requirements (from study initiation through posting of results) are met.
¿ Develop a strong understanding of the pipeline, product portfolio and business needs.
¿ Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
¿ Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
Qualifications:
¿ A Bachelor's degree in Biological Science or related discipline, with a minimum of 6 years related scientific, technical, or clinical research experience.
¿ Previous experience in the Medical Device industry is preferred
¿ Previous experience developing strategies to generate clinical evidence is preferred.
¿ Understanding of Good Clinical Practices is required.
¿ Understanding and application of regulations and standards applied to medical device clinical research is preferred.
¿ Strong experience in budget planning, development and oversight is preferred.
¿ Advanced technical writing skills is required.
¿ Demonstrable track record of success managing multiple projects simultaneously with little to no supervision is required.
¿ Strong presentation skills and the ability to influence others is required.
¿ The ability to travel domestically and internationally up to 10% is required
Prescreening Questions:
Do you possess a Bachelor's degree in Biological Science or related discipline, with a minimum of 6 years related scientific, technical, or clinical research experience? (REQUIRED)
Do you have previous experience in the Medical Device industry? (PREFERRED)
Do you have previous experience in developing strategies to generate clinical evidence (PREFERRED)
Do you have experience in the Orthopaedic/Trauma disease states? (PREFERRED)
Which skills and experience do you have? Please select all that apply:
¿ Understanding of Good Clinical Practices (PREFERRED)
¿ Understanding and application of regulations and standards applied to medical device clinical research (PREFERRED)
¿ Strong experience in budget planning, development and oversight (PREFERRED)
¿ Advanced technical writing skills (REQUIRED)
¿ Demonstrable track record of success managing multiple projects simultaneously with little to no supervision (REQUIRED)


¿ Strong presentation skills and the ability to influence others (REQUIRED)
¿ The ability to travel domestically and internationally up to 10% (REQUIRED)
¿ None of the above