Back to jobsIndependently leads clinical execution of one or more studies; may be accountable for program level clinical deliverables
May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
Represents the clinical science team in internal protocol review committees, partners with/supports the Clinical Research Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions
Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests
Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice.
Sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents 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
Collaborates with Medical Safety and Pharmacovigilance on the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations
Collaborates with the medical monitor on establishing and managing External Data Monitoring Committees and Adjudication Committees, including chartering, data provision and presentation of data, and documentation and dissemination of Committee recommendations, as appropriate
Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues
Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)
Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review
Ensures TMF compliance for clinical documents
Provides clinical input and review of the Clinical Study Report
Ensures 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
May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests)
Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution
May have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop others
