Johnson & Johnson Warsaw , IN 46581
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Clinical Research Project Manager (Senior Clinical Research Scientist) to be located in either Warsaw, Indiana, USA, Leeds, UK, or remotely in the United States.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, we are proud to be an equal opportunity employer.
Operating on behalf of the Medical Device Group, the Senior Clinical Research Project Manager (Senior Clinical Research Scientist) will contribute to the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects
The Senior Clinical Research Project Manager (Senior Clinical Research Scientist) will:
Contribute to delivery of assigned clinical projects, including development of Global EGS / EDS to support New Product Development (NPD) and Life Cycle management (LCM) within the assigned platforms, through collaborative relationships with all relevant Clinical Research partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.), ensuring alignment.
Contribute towards development of clinical trial protocols, informed consents, investigator brochures, and other study materials;
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;
Contribute to delivery of assigned clinical projects, 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 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 critical assessment of the literature and drafting Clinical Evaluation Reports (CERs) for new products;
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 in the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
Support the collaboration with investigators to deliver and disseminate evidence;
Ensure registration on 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 supervision, dependent on project complexity. Independent decision-making for simple situations but requires guidance for complex situations. Senior staff member will review work during development, dependent on level of complexity, and upon completion
A Bachelor's degree (or University equivalent) in Biological Science or related discipline, with a minimum of 4 years related scientific, technical, or clinical research experience is required
Experience in the Code of Federal Regulations (CFR) or ISO14155 for conducting clinical research trials is required
Orthopedic device experience is preferred
Investigational Device Exemption (IDE) experience is preferred
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 is required
Ability to provide strategic and scientific clinical research input across New Product Development (NPD) and Lifecyle Management (LCM) projects, with a proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
Comprehensive understanding of clinical trial regulations across multiple regions is preferred
Ability to lead small teams to deliver critical milestones is preferred
Ability to collaborate across different functional areas within Clinical Research to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.) to meet business objectives is required
Ability to develop skills necessary to build collaborative relationships with key internal and external partners and stakeholders is required
This role will be located in either Warsaw, Indiana, USA, Leeds, UK, or remotely in the United States, and will require up to 10% domestic and international travel
United Kingdom-England-Leeds, North America-United States, United Kingdom-England-Leeds, United Kingdom-England-Leeds
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD