Lead Clinical Study Manager

Role Summary

Lead Clinical Study Manager, based remotely and reporting to the Clinical Operations Leadership team. You will lead study operational strategy and planning and oversee execution of clinical studies for assigned programs, supporting the clinical strategy defined in the Clinical Development Plan.

Responsibilities

• Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
• Oversee Strategic Partners and/or other CROs and other third-party vendors to meet obligations described in ICH-GCP and business objectives.
• Lead the development of the Operational Strategy during Early Engagement with Strategic Partner(s) and/or other CROs; ensure accurate assumptions and robust risk management plans.
• Provide oversight/support/guidance to Strategic partners/CROs to address and resolve study issues rapidly.
• Manage study budgets and external spend; collaborate with Clinical Operations Program Lead(s), Global Program Management, and Finance to maintain accurate budgets, enrollment, and gaiting; communicate status, cost and issues to stakeholders; escalate vendor issues as needed.
• Oversee vendor selection, budget and contract negotiation, and supervision of performance; escalate issues to governance committees when warranted.
• Review and approve key monitoring documents/plans; monitor study plans and actions; manage study team meetings and minutes; review protocol deviations to identify site trends; monitor risks and implement mitigations.
• Collaborate with data management to align database timelines with strategy and tactical plans, ensuring linkage to filing/registration and CSR timelines.
• Ensure studies are “inspection ready” at all times; participate in regulatory inspections as needed.
• Represent the Lead Clinical Study Manager role in functional initiatives or working groups; mentor new or junior CSMs; support COPL as required.

Education

• BS/BA in a health-related, life science, or technology-related field, or equivalent combination of education, training and experience.
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training may supplement experience requirements.

Experience

• 6+ years in the pharmaceutical industry and/or clinical research organization, including 4+ years in clinical study management/oversight; experience in early phase and/or Phase 2/3, global/international studies; experience in more than one therapeutic area is advantageous.
• Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) and local country requirements.
• Demonstrated excellence in project/program management and matrix leadership; excellent communication, teamwork, organizational, interpersonal, and problem-solving skills; fluent business English (oral and written).

Additional Requirements

• Travel: Requires approximately 5-20% travel, including overnight and international travel to other sites and partners.