DePuy Synthes, a member of Johnson & Johnson's Family of
Companies, is recruiting for a Clinical Research Manager to be located in
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.),
- 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,
- 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
- 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
- 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.
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Research non-MD