Clinical Project Operator

Johnson & Johnson Horsham , PA 19044

Posted 2 months ago

Janssen Scientific Affairs, LLC., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Project Scientist, to be located in Horsham, PA!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Scientific Affairs, LLC is part of the Janssen Pharmaceutical Companies.

Are you interested in joining a team with dynamic strengths delivering outstanding results to our customers? Apply now for this exciting opportunity!

The Clinical Project Scientist, is responsible for implementation of Investigator Initiated Studies) (IIS), collaborative group study, and early access/ led access studies. In this role, the individual will be required to work in collaboration with Therapeutic Area Leads (TALs), Medical Directors (Study Responsible Physicians [SRP] and/or Study Responsible Scientists[SRS]), Medical Science Liaison (MSL) team, Global Development (GD) and Contracting group. The candidate needs to work with the above partners to ensure that studies are executed in a timely and compliant fashion to deliver data to support evidence generation needs in the US. Additionally, candidate will need to act as point of contact with external Investigators for protocol intake/review, contract/budget negotiations, supervise clinical supply demand, lead and track protocol deliverables, including data generation activities (study reports, manuscripts, congress publications).

Essential functions:

  • Oversees and supports all aspects of internal review and approval of IIS, collaborative clinical, and/or early access/ managed access studies.

  • Collaborate with Investigators/staff, Safety, Compliance, supply chain and R&D) to build relationships to ensure timely execution of IIS/collaborative studies.

  • Actively contributes to protocol/Informed consent planning and development. Collaborates with TA lead, Medical Directors and counterparts in Global Medical Affairs, as needed, to understand asset strategy and data generation priorities across an asset or number of assets.

  • As appropriate, manage monthly/periodic meetings to monitor/ track ongoing status of assigned studies and may assist in IIS/collaborative proposal intake, review, and tracking.

  • Collaborate with medical/GD personnel to assist with execution of clinical studies;development, management, and tracking of trial budgets.

  • Proactively interface with internal and external stakeholders to resolve contract/budget negotiation issues. Development and implementation of risk mitigation strategies as well as study timeline management.

  • Assist with tracking and managing adverse event data collection across trials (IIS and company sponsored); and where appropriate, incorporation into obligatory regulatory documents. Interface with GCO Safety personnel and Global Medical Safety.

  • Ensure compliance with internal J&J SOPs including local and global health authority regulations and guidelines.

Qualifications

  • A minimum of a Bachelor's Degree is required, and advanced degree is preferred; knowledge of Oncology therapeutic area is highly preferred.

  • A minimum of 6 years of experience within the pharmaceutical/development industry is required; experience in supporting, overseeing or managing IIS/collaborative studies is desirable.

  • Proven presentation and analytical skills, ability to work efficiently and lead cross-functional teams is required.

  • Able to think creatively, critically, and proactively, with strong problem solving skills. Collaborative and flexible in personal interactions at all levels of the company.

  • Previous experience reviewing contracts and budgets is preferred.

  • The position will be based in Horsham, PA and may require up to 15% travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Pennsylvania-Horsham-800/850 Ridgeview Drive

Organization

Janssen Scientific Affairs, LLC (6120)

Job Function

R&D

Requisition ID

2105965593W

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Clinical Project Operator

Johnson & Johnson