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8 months 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 Clinical Research Project Manager to be located
in Leeds, UK.

DePuy Synthes Companies of Johnson & Johnson is the
largest, most creative 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 creative,
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
Clinical Research Project Manager 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)

* Contribute
to delivery of assigned clinical projects, including development of Global
EGS / EDS to support New Product Development and Life Cycle management
within the assigned platforms, through reciprocal 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
* Take
a leadership role in the 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
* Ensure
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 dedications (deliver on time,
within budget and in compliance with regulations and SOP);
* Develop
positive 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
* 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 keen understanding of the pipeline, product portfolio and business
* 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
* Generally
manages work with supervision, dependent on project complexity.
* Independent decision-making for simple situations but requires mentorship
for complex situations. Senior staff member will review work during
development, dependent on level of complexity, and upon completion
* May
require up to 10% domestic and international travel


Qualifications & skills:


* A
Bachelor’s degree in Biological Science or related discipline, with a
minimum of 6 years related scientific, technical, or clinical research
* A
Master’s degree with a minimum of 4 years’ experience or a PhD/MD/PharmD
with a minimum of 2 years preferred
* Experience
in the Code of Federal Regulations (CFR) or ISO14155 for conducting
clinical research trials
* Deep
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
* Ability
to lead small teams to deliver critical achievements
* Ability
to develop skills necessary to build reciprocal relationships with key
internal and external organizations and partners
* Ability
to provide strategic and scientific clinical research input across various
types of 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
* Ability
to collaborate across different functional areas within Clinical Research
to ensure alignment with governance processes (assigning roles and
responsibilities, setting priorities, leading deliverables, etc.) to meet
business objectives
* Advanced
technical writing skills, such as scientific publications, protocol


* Orthopedic
device experience
* Investigational
Device Exemption (IDE) experience
* Comprehensive
understanding of clinical trial regulations across multiple regions

Primary Location
United Kingdom-England-Leeds-
Depuy Int'l Ltd. (8722)
Job Function
Clinical Research non-MD
Requisition ID

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