The Clinical Development Scientist (Manager) provides support for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies.
Requirements
- Provides clinical support for one or more studies
- Contributes to development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
- Supports the study team in internal protocol review governance submissions and interactions
- Contributes to Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests
- May provide clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
- Performs clinical data review in accordance with the data review plan and clinical data review best practices; may present data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock
- Reviews safety data and may contribute to clinical document updates in response to emerging safety profile; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
- Contributes to clinical activities consistent with the approved Risk Management Plan
- Supports establishment and management of External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations
- Contributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleagues
- May participate in investigator meeting; may contribute to ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
- Contributes to clinical response development, delivery, documentation, and curation (e.g., in FAQ) for questions relating to clinical aspects of the protocol
- May contribute to protocol deviation sub-category development; ensures protocol deviations identified during clinical data review are reported; contributes to protocol deviation management and reconciliation; may contribute to protocol deviation trends review
- Ensures TMF compliance for clinical documents
- Provides clinical input and review of the Clinical Study Report
- Provides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to primary publications
- Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
