Clinical Research Manager
Location:
Raynham , Massachusetts
Posted:
February 08, 2017
Reference:
9773161227-en-us

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Manager to be located in Raynham, MA.


DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.


Operating on behalf of the Medical Device Group, the Clinical Research Manager will have strong scientific and global medical device expertise to provide insights and strategic direction to manage highly complex regulated studies, develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.

 
The Clinical Research Manager will:

  • Be responsible for Clinical R&D activities for assigned projects, including development and delivering appropriate Global EGS / EDS to support New Product Development (NPD) and Life Cycle management (LCM) within the assigned platforms, with 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.
  • 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).
  • Ensure input and strong alignment from key regional Medical Device (MD) Clinical Research leads and other strategically important countries/regions in the development of the EGS / EDS.
  • Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs and to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, Clinical Evaluation Reports (CERs), etc
  • Contribute in 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.
  • Be responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc.
  • Foster strong relationships with external stakeholders to shape and influence relevant policies, etc., and partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement.
  • Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement

 


Qualifications

  • 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.
  • A minimum of 1-2 years of people management related experience is required preferred for this role.
  • Experience in the Code of Federal Regulations (CFR) for conducting clinical research trials is required.
  • Orthopaedic (Spine) device 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 strongly 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.
  • 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 30% domestic and international travel.



Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Clinical Research non-MD

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