Senior Clinical Trial Manager

Position Summary

The successful candidate will have a strong background leading early phase clinical trials. This individual will use outstanding cross-functional skills to achieve study and program goals and will develop a solid understanding of the clinical indications being pursued including knowledge of the patient needs, development plan, applicable regulatory guidance as well as the competitive landscape in the therapeutic space.

Key Responsibilities

• Plan, drive and oversee all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines in close collaborations with key stakeholders and Clinical Research Organizations (CROs)
• Drive implementation of clinical operational strategy for successful delivery of assigned clinical studies
• Use operational and therapeutic expertise to optimize trial design and execution and collaborate with the study team to accelerate clinical trial timelines
• Provide oversight and management for all relevant CROs and vendors including contracting and clinical budgets; develop contingency plans for clinical trials
• Coordinate and lead study team meetings and update the Program Team on timelines and milestones for the study
• Contribute to the development of study documentation including protocol review, creating study plans, ICFs, and designing CRFs
• Contribute to CRO/vendors identification, qualification and selection processes as applicable
• Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting
• Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data
• Oversee high quality implementation, execution and delivery of studies by CROs in alignment with timeline and budget plan
• Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight
• Ensure compliance with internal policies and procedures, GCPs, and applicable regulations; ensure inspection readiness
• Oversee Vendor Contracts and Clinical Study Budget, report progress to finance team
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
• Oversee TMF management and review TMF documentation as necessary
• Limited travel possible to field sites to supervise and/or monitor clinical studies (<25%)

Required Qualifications

• Bachelor’s Degree; Life Sciences preferred. Advanced degree desirable.
• 8+ years of relevant clinical development and operations experience, in clinical operations leadership roles, leading global clinical studies/programs, with track records of initiating and delivering early phase trials
• Experience in rare diseases and early phase studies (including FIH studies) is highly desirable
• Strong leadership skills driving large cross functional teams
• Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements and ICH GCP, including experience with global regulatory inspections
• Excellent critical and strategic thinking, with strong ability to understand the big picture as well as the important details that may impact the big picture
• Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications
• Excellent communicator and influencer, able to persuasively convey ideas and data, verbally and in writing