Senior Clinical Trial Manager

About This Role

This Senior Clinical Trial Manager will be accountable for achieving clinical deliverables within specified timelines and budget for complex studies, ensuring compliance with ICH GCP. The role involves managing clinical operational and quality aspects, leading regional efforts or acting as Clinical Study Manager, and overseeing clinical teams and vendors.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies of moderate to high complexity, ensuring compliance with ICH GCP
• Assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities, or take on additional responsibilities such as process improvements or managing complex programs
• Ensure efficient and thorough study start-up by overseeing CRO clinical teams, reviewing site feasibility reports, and supporting site selection
• Verify timely collection of essential study documents, including regulatory and ethics committee documents for submission
• Support and ensure completion of all specific EDC system tasks under clinical responsibility within defined timelines
• Support the Clinical CRO in training CRAs on study-specific operational activities and participate in organizing monitor and investigator meetings
• Customize and follow site Key Risk/Performance Indicator templates as agreed in the oversight plan
• Validate final clinical study documents prepared by the Clinical CRO, such as study manuals and monitoring plans
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan and contribute to the Master Action Plan (MAP)
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
• Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines, providing status updates, and reviewing monitoring visit reports
• Continuously monitor clinical trials to assess performance and ensure contractual obligations are met
• Communicate with study sites regarding issues such as protocol, patient participation, and case report form completion

Requirements

• 5+ years of experience in clinical trial management
• 1+ year of leadership responsibility
• Previous experience in both onsite monitoring and a CTM role
• Global CTM experience
• Highly experienced in CRO and monitoring oversight
• Strong vendor management skills
• Advanced mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills (remote and onsite experience)
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Solid knowledge of medical/therapeutic areas and medical terminology

Qualifications

• 5+ years of experience that provides the knowledge, skills, and abilities to perform the job, with 1+ year of leadership responsibility.

Nice to Have

• 2+ years of Neurology or Rare Disease experience
• Onsite monitoring experience