Clinical Research Project Manager, Investigator Initiated Studies (Clinical Research Scientist)

Job description

The Johnson and Johnson Medical Device Business Services, Inc. is recruiting for a Clinical Research Project Manager, Investigator Initiated Studies (IIS) to be located at one of the following Medical Device company locations: Irvine, CA; Somerville, NJ; Cincinnati, OH; West Chester, PA; Raynham, MA; Warsaw, IN.

The Clinical and Medical Strategic Operations within the Medical Devices Business Services is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Devices companies.

The 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. The teams will have primary responsibility for defined areas of clinical program operations, execution and dissemination.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Clinical Research Scientist for IIS will be responsible for the oversight and daily management of post-market clinical research activities and Investigator Initiated Study (IIS) Program ensuring compliance with legal, regulatory, and company policies & process requirements.

· Work with global medical/clinical colleagues in daily management of IIS in other countries outside of United States
· Be the point person for questions regarding the IIS program and to receive and review applications for completeness and suitability; prepare and make available application and support materials to review committee; schedule and lead review meeting; and communicate with IIS applicants
· Manage the IIS submission portal and maintenance of IIS database
· Coordinate meetings and recording of meeting minutes
· Ensure the IIS proposals are reviewed and approved by a cross-functional committee
· Work collaboratively with legal/compliance and study institution/principal investigator on contract request, development, negotiation and execution
· Manage device orders, shipments, and returns
· Establish and maintain a strong partnership with the Clinical Teams and all relevant Clinical R&D partners and cross-functional partners (Franchise R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access) to manage the IIS programs, including external research (e.g., external registries) and to contribute to the development of and deliver appropriate IIS relevant input to support Global Evidence Generation Strategy (EGS) to support new product development (NPD) and life cycle management (LCM) within the assigned platforms
· Support management of internal evidence database and monthly literature review
· Collaborate with teams to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
· Budget management and forecasting
· Manage clinical study milestones, invoices, payments and needs assessment
· Ensure dissemination of all IIS evidence generated
· May be involved in other tasks to support IIS and process optimization activities as needed;
· Generally, manages work with limited supervision

Desired profile

Qualifications :

·  A Bachelor's degree in a scientific related discipline is required
·  A minimum of 2 years' professional experience is required; previous experience in a Pharmaceutical, Biotech, Medical Device, or Clinical Research organization is preferred
·  Experience with clinical study management and clinical research contract negotiation is preferred
·  Prior experience managing investigator initiated (IIS) studies is strongly preferred
·  Knowledge of medical device/pharmaceutical industry processes is preferred
·  Must be detail oriented, highly organized, and able to work independently
·  Trained and efficient in Microsoft Project is preferred
·  Ability to multi-task in a fast-paced environment is required
·  This position may be located at any of the following Johnson & Johnson Medical Device company locations, Irvine, CA; Somerville, NJ; Cincinnati, OH; West Chester, PA; Raynham, MA; or Warsaw, IN, and may require up to 10% domestic travel