Clinical Development Medical Senior Manager

Job Summary

The Clinical Development Medical Senior Manager is accountable for the:
Medical & scientific integrity of the study and well-being of participants enrolled in one or more clinical trials. Timely delivery of high-quality protocols and clinical study execution. Clinical data, safety, risk review and mitigation. Use of AI-enabled clinical development and digital approaches to support excellence in clinical trial design and execution.

• Provides input to support development of the protocol design document.
• Leads or supports development and timely delivery of a quality protocol which maximizes operational efficiency, trial quality and participant / site engagement and minimizes the likelihood of amendments or quality issues.
• Provides clinical input to the DORA process to ensure application of data standards, optimized data collection, and timely and thorough data review using clinical data review best practice.
• Responsible for providing clinical input to the SAP, TLFs, and BDR.
• Manages Informed Consent Documents (ICDs) as per SOP including responses to external stakeholder questions.
• Provides clinical input to development of the Integrated Quality Management Plan (IQMP) as per SOP.
• Supports establishment and oversight of independent study committees, such as Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Inputs to, reviews, and approves the Risk Management and Safety Review Plan.
• Ensures activities are conducted consistent with the approved plan and partners with key stakeholders, including clinical operations and the safety risk lead, to develop and implement any risk mitigations.
• Reviews and approves country selection, develops site selection criteria and ensures protocol specific training.
• Approves investigator meeting plans.
• Serves as the primary contact with external investigators and internal study team for questions relating to medical or clinical aspects of protocol.
• Reviews, reports and manages protocol deviations and approves protocol amendments as per SOP.
• Proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety, and protocol deviation review.
• Reviews patient level and cumulative data per the data review plan across one or more studies.
• Reviews safety data, SAE reports, TMEs, DMEs, and ICDs as required.
• Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
• Performs medical monitoring for one or more clinical trials.
• Ensures Inspection Readiness for clinical documents.
• Supports appropriate interpretation and communication of clinical trial data.
• Inputs and reviews the Clinical Study Report including the review of narratives.
• Responsible for supporting disclosure of safety and efficacy data and trial conclusions.
• Contributes to primary publication of clinical trial results.
• Provides clinical support to the study team or clinical program in response to audits or inspections.
• Supports clinical sections of regulatory filings, including the Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, Periodic Safety Update Reports, and regulatory authority responses.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
• Accountable for compliance with internal and external standards.
• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
• Uses AI-enabled tools and analytics to support clinical data review, signal…