DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Manager to be located in Raynham, MA to support the Spine Franchise.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
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.
The Clinical Research Manager will have strong scientific and global medical device expertise to provide insights and strategic direction to manage highly complex pre-market or post market clinical studies and develop innovative evidence generation/dissemination strategies (EGS / EDS) for New Product Development projects for DePuy Synthes Spine. Responsibilities include:
- Be responsible for Clinical Research activities for assigned projects, including developing appropriate Global clinical study strategies to support New Product Development (NPD) and Life Cycle Management (LCM), with collaborative relationships with all relevant cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.), ensuring alignment.
- Be responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BioStats & Data Management (BSDM) teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and internal procedures).
- Lead team of clinical research scientists to design appropriate clinical trials and registries to meet the NPD / LCM needs and to ensure appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, Clinical Evaluation Reports (CERs), etc.
- Contribute in clinical scientific discussions with regulatory agencies / European notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations.
- Be responsible for team’s interface and collaboration with Orthopedic/ Neurological surgeons, site study staff, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc.
- Partner with internal departments to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement.
- Strong leadership required in alignment with J&J Leadership Imperatives:
- Connect, Shape, Lead, Deliver as noted below.
- Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
- Shape – build strong relationships with external stakeholders to shape and influence relevant policies
- Lead – develop talent to provide strategic and scientific clinical research capability, including responsibility for professional development of direct reports
- Deliver – ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs
A Bachelor’s degree with a minimum of 10 years clinical research experience (this can be a combination of industry/academic related experience). OR a PhD or equivalent degree in Biological Science or related discipline with a minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research is required.
A minimum of 1-2 years of people management related experience is required for this role.
Demonstrated competency in protocol writing, analysis/interpretation of literature, report writing, and project budgeting is required.
Experience in the Code of Federal Regulations (CFR) for conducting clinical research trials is required.
Orthopaedic (Spine) device clinical trial experience is preferred.
Post-Market observational or registry study experience is preferred.
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required.
Investigational Device Exemption (IDE) experience is preferred.
Ability to provide strategic and scientific clinical research input across projects, including complex and / or transformational 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, specifically the Medical Device Regulation for CE Marking
Ability to lead teams to deliver critical milestones, including complex projects is required.
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.
Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is required
This role will be located in Raynham, MA and will require up to 20% domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Medical Device Business Services, Inc (6029)
Clinical Research non-MD