The Clinical Project Scientist is a responsible member of a clinical team dedicated to the development and execution of clinical trials and the clinical and operational implementation of a complex compound program. The Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Specifically, the Clinical Scientist provides input to the clinical development plan, develops the clinical trial protocol and clinical trial materials, takes responsibility for coordinating completion of clinical study reports, and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with a number of different disciplines. The position will also have responsibility for various activities associated with safety monitoring and assessment of relevant clinical studies/programs, and will have clinical ownership of or provide clinical support for various regulatory documents, including the Investigator Brochure, the Risk Template of the Informed Consent form, the Development Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report (PBRER) and the Safety Risk Management Plan. The Clinical Scientist may be asked to contribute to due diligence efforts in the therapeutic area.
- Supports preparation of clinical development plans, trial protocols, and supports the Global Clinical Development Operations group with trial set up, conduct, and monitoring, and database locks.
- Integral in the collection and analysis of clinical trial data, and assists with completion of clinical study reports
- Support the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information for review by the Molecule Responsible Physician (MRP) and/or Study Responsible Physicians (SRPs) or Safety Management Team (SMT).
- Assists in the evaluation of adverse events and supports the interpretation and reporting of results. This will include attending and presenting at SMT
- Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
- Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
- Responsible for data review in conjunction with other clinical team members prior to database locks
- May be asked to participate in safety event adjudication efforts.
- Participate in cross-Pharma initiatives as requested.
- Participate in Immunology TA initiatives as requested
- Participate on and may lead cross-functional teams for evaluation of new product ideas
- Reviews medical literature and related new technologies
A minimum of a Bachelor's degree is required, and advanced degree (e.g., MS, RN, RD, PhD or PharmD) is preferred. A minimum of at least 5 years of clinical research and development experience within the pharmaceutical industry or experience as clinical research coordinator in non-industry setting is required.
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID
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