Clinical Research Study Lead/Project Lead (Staff Clinical Research Scientist)
Multiple Locations: Warsaw,United Kingdom
Functions: Clinical Research non-MD Start a new job search
Job Description Requisition
The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Staff Clinical Research Scientist located in Warsaw, IN; Leeds, England; Westchester, PA; OR Raynham, MA. The location preference would be for Warsaw or Leeds.
The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies. The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management. All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle. Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.
- Participate in product development Project Core Team (PCT) activities, provide clinical input and complete clinical tasks.
- Responsible for front end activities related to clinical feasibility including literature reviews.
- Develop and execute global evidence generation and publication strategies with input from cross functional teams. Specifically, the strategic nature of this role includes a strong focus on meeting worldwide market access needs of multiple stakeholders (patients, physicians, providers, payors and policy makers) that can contribute to shaping appropriate evidence strategies, and distill the high level goals into actionable studies needed to support product claims.
- Draft clinical trial protocols with minimal supervision.
- Draft study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.
- Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
- This experienced professional will be responsible for Clinical Research Portfolio management within designated DePuy Synthes Operating Company, as well as, fostering strong, productive relationships with colleagues within the organization.
- He/she will be responsible for the management of all clinical studies except for high-risk or complex studies, and may lead project teams.
- He/she may assist other leaders with the management of more complex, high-risk studies. He/she may also lead the management a large segment of the Operating Company clinical portfolio.
- Primary perform the role of Clinical Study Lead, and may perform other roles including Clinical Operations Lead.
- Manage non-regulated (Investigator Initiated, Registries, or company sponsored post-market studies) and regulated studies (IDE, HDE, Post-Approval, 522).
- Assist with high complexity studies and may manage components of studies/programs.
- Responsible for Clinical Evaluation Reports for new products
- Plan for study budgets and manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures with minimal supervision.
- Manage and monitor the progress of assigned Investigator Initiated Studies, including interacting with the primary Investigator and site staff, verify milestones, track budgets, and generate evidence according to agreements.
- Develop collaborative relationships with other functional areas within the Office of Science and Technology and the Operating Company.
- Develop strong collaborative relationships with Study Core Team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
- Maintain registration on from study initiation through posting of results.
- Collaborate with investigators and internal stakeholders to support publication strategy execution.
- Develop materials to be used by Clinical Operations for study execution (Investigator Brochures, training materials, etc.).
- May support the review of clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs.
- Apply high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs.
- Develop a strong understanding of the Operating Company product portfolio and pipeline, and business needs.
- Ensure the completion of required templates and documents, and maintenance of records.
- Provide leadership to project teams and mentor other clinical staff.
- BS/BA degree with 6 years of relevant experience OR Master’s with 4 years OR PhD/MD/PharmD with 2 years is required.
- A degree in Life Sciences, Biomedical Engineering, or related field is required.
- Relevant industry certifications preferred (., CCRA, RAC, CDE).
- Previous medical device experience preferred.
- Previous clinical research experience required
- Orthopedic device experience desirable.
- Understanding of Good Clinical Practices preferred.
- Application of scientific research principles preferred.
- Understanding and application of regulations and standards applied to medical device clinical research is preferred
- Ability to travel domestically and internationally up to 20%
Johnson & Johnson is an equal opportunity employer
Depuy Orthopaedics. Inc.
Clinical Research non-MD