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about 1 month ago
Johnson & Johnson
Location: Leeds
Job type: Permanent
Sector: Market Research Agency
Category: Project Management Jobs
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 javascript:void(0); 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

Qualifications

* 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

Primary Location
United States-Indiana-Warsaw
Other Locations
North America-United States, United Kingdom-England-Leeds, United Kingdom-England-Leeds, United Kingdom-England-Leeds
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Clinical Research non-MD
Requisition ID
00001DGC

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