The Johnson and Johnson Medical Device (MD) Sector Clinical
Research and Development Center of Excellence (CR&D COE) is recruiting for
a Staff Clinical Research Scientist located in Warsaw, IN; Leeds, England;
Westchester, PA; OR Raynham, MA. The location preference would be for Warsaw or
The MD CR&D COE is being created to support all clinical
activities across all business units within the Johnson & Johnson Medical
Device companies. The COE organization
is based on three functional teams: Franchise, Operations and Biostatistics
& Data Management. All three teams
share accountability for the successful development and delivery of clinical
evidence globally to internal and external (5Ps) stakeholders that drives
innovation in surgical solutions and that optimizes the product lifecycle. Each team within CR&D COE will have
primary responsibility for defined areas of clinical program development,
execution and dissemination.
- Participate in product development Project Core
Team (PCT) activities, provide clinical input and complete clinical tasks.
- Responsible for front end activities related to
clinical feasibility including literature reviews.
- Develop and execute global evidence generation
and publication strategies with input from cross functional teams. Specifically, the strategic nature of this
role includes a strong focus on meeting
worldwide market access needs of multiple stakeholders (patients, physicians, providers,
payors and policy makers) that can contribute to shaping appropriate evidence
strategies, and distill the high level goals into actionable studies needed to
support product claims.
- Draft clinical trial protocols with minimal
- Draft study reports with minimal supervision 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.
- Keep management informed of key developments and
issues that impact clinical strategy and portfolio management.
- This experienced professional will be
responsible for Clinical Research Portfolio management within designated DePuy
Synthes Operating Company, as well as, fostering strong, productive
relationships with colleagues within the organization.
- He/she will be responsible for the management of
all clinical studies except for high-risk or complex studies, and may lead
- He/she may assist other leaders with the
management of more complex, high-risk studies. He/she may also lead the
management a large segment of the Operating Company clinical portfolio.
- Primary perform the role of Clinical Study Lead,
and may perform other roles including Clinical Operations Lead.
- Manage non-regulated (Investigator Initiated,
Registries, or company sponsored post-market studies) and regulated studies
(IDE, HDE, Post-Approval, 522).
- Assist with high complexity studies and may
manage components of studies/programs.
- Responsible for Clinical Evaluation Reports for
- Plan for study budgets and manage the
development of Investigator agreements and site contracts within fair market
value (FMV), vendor agreements, payments, and financial disclosures with
- Manage and monitor the progress of assigned
Investigator Initiated Studies, including interacting with the primary
Investigator and site staff, verify milestones, track budgets, and generate
evidence according to agreements.
- Develop collaborative relationships with other
functional areas within the Office of Science and Technology and the Operating
- Develop strong collaborative relationships with
Study Core Team and others to ensure study progress for assigned projects and
that issues are identified and communicated to leaders.
- Maintain registration on www.clinicaltrials.gov
from study initiation through posting of results.
- Collaborate with investigators and internal
stakeholders to support publication strategy execution.
- Develop materials to be used by Clinical
Operations for study execution (Investigator Brochures, training materials,
- May support the review of clinical information
required for periodic safety and post-market surveillance reviews in
collaboration with Medical Affairs.
- Apply high standards of critical thinking,
analysis, collaboration, and communication for the advancement of clinical
- Develop a strong understanding of the Operating
Company product portfolio and pipeline, and business needs.
- Ensure the completion of required templates and
documents, and maintenance of records.
- Provide leadership to project teams and mentor
other clinical staff.
- BS/BA degree with 6 years of relevant experience
OR Master’s with 4 years OR PhD/MD/PharmD with 2 years is required.
- A degree in Life Sciences, Biomedical
Engineering, or related field is required.
- Relevant industry certifications preferred
(i.e., CCRA, RAC, CDE).
- Previous medical device experience preferred.
- Previous clinical research experience required
- Orthopedic device experience desirable.
- Understanding of Good Clinical Practices
- Application of scientific research principles
- Understanding and application of regulations and
standards applied to medical device clinical research is preferred
- Ability to travel domestically and
internationally up to 20%
Johnson & Johnson is an equal opportunity employer
United States-Indiana-WarsawOther Locations
North America-United States-Massachusetts-Raynham, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-United Kingdom-England-LeedsOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Research non-MD