Summary of Key ResponsibilitiesThe Senior Study Manager is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.
Key Responsibilities- Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.
- Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).
- Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI's and metrics)
- Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
- Identify risks and ensure mitigations and contingencies are being initiated and followed through
- Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
- Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
- Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
- Participate in process improvement activities at a trial and department level as needed
- Mentor & support onboarding of new team members, particularly those in Study Management.
- Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
- Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
- Support and provide input into internal governance presentations & updates
- Ability to travel approximately 10% but flexibility to go over or below as per business need).
Qualifications - BS/ BA degree is required.
- Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company managing on Phase 1-4 global clinical trials end to end.
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