(Sr.) Clinical Trial Manager

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Requirements:

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• 8+ years’ experience in the life sciences industry.
• 5+ years of Project Management or Clinical Trial Management experience.
• Experience in rare disease, CNS, and/or Oncology preferred.
• Strong communication, collaboration, and interpersonal skills.
• Excellent analytical and organizational skills.
• Working knowledge of project management principles; PMP certification is an advantage.
• Knowledge of global regulatory requirements and ICH guidelines.
• Ability to find creative solutions to timelines and budget issues.

Responsibilities:

• Leads planning and communication with cross-functional teams for clinical trial execution.
• Reviews and approves plans from CROs and vendors for compliance with GCP and regulations.
• Represents the study team in the design and delivery of studies within timelines.
• Oversees CROs and vendors to ensure protocol compliance and escalate concerns.
• Develops and manages critical study documents and audit preparation.
• Finalizes clinical study-related documents and prepares contingency plans.
• Drives trial activities including site activations and database lock.
• Maintains dashboards and reports project progress to management and governance teams.
• Facilitates meetings with prepared materials and follow-ups.
• Provides status reports on timelines and accruals.