Johnson & Johnson Careers
Staff Clinical Research Project Manager (Staff Clinical Research Scientist)
Requisition ID: 6972180717
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Staff Clinical Research Project Manager (Staff Clinical Research Scientist) This role is based in Somerville, NJ and may require approximately 15% travel.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products
On behalf of the Biosurgery PCM Group, this clinical research professional will be responsible for the supporting the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
POSITION DUTIES & RESPONSIBILITIES
- Contribute to the development and deliver appropriate 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, MCP, 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.
- Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and 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 IDE, PMA, 510(k), and other regulatory submissions.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement;
- Foster strong relationships with key investigators to deliver evidence.
- Ensure registration on PharmaCM (www.clinicaltrials.gov) from study initiation through posting of results.
- 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.
- May be involved in other tasks to support clinical research activities as needed.
- Generally manages work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion.
- Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
- Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects;
- Proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
- Ability to lead study teams to deliver critical milestones;
- Ability to collaborate across different functional areas within PCM, R&D teams to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;
- Leadership requirement – ability to influence, shape and lead without direct reporting authority;
- A Bachelor’s degree in Biological Science or related discipline, with a minimum of 6 years related scientific, technical, or clinical research experience is required
- Understanding of Good Clinical Practices is required Previous Medical Device clinical research experience is preferred
- Strong technical/medical 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 Prior experience with global pre & post market clinical studies is preferred
- Safety reporting experience in clinical studies is preferred
- Understanding and application of regulations and standards applied to medical device clinical research is preferred
- This role will be located in Somerville NJ and will require up to 15% domestic and international travel
United States-New Jersey-Bridgewater
Ethicon Inc. (6045)
Clinical Research non-MD