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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 Staff Clinical Research
Project Manager (Staff Clinical Research Scientist) to be located in either
Warsaw, Indiana, USA; Raynham, MA, USA; or Leeds, UK.

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 Staff Clinical Research Project Manager (Staff 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 Staff Clinical Research
Project Manager (Staff 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,
Health Economics and Market Access, Epidemiology, 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 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;
* Lead in the interpretation and dissemination of all
evidence generated, including abstracts, manuscripts, and use of
clinical data/evidence for market access and reimbursement to include
authorship, as appropriate;
* 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 in Biological Science
or related discipline, with a minimum of 6 years related scientific,
technical, or clinical research experience is required; A Master’s degree
with a minimum of 4 years’ experience or a Doctorate degree (PhD/MD/PharmD)
with a minimum of 2 years is preferred
* 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 Lifecycle
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
* Advanced technical writing skills, such as scientific
publications, 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; Raynham, MA USA or Leeds, UK and may require up to 25%
domestic and international
travel

Primary Location
United States-Indiana-Warsaw
Other Locations
United States-Massachusetts-Raynham, 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
00001DGL

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