Senior Manager – Clinical Research Support

Senior Manager – Clinical Research Support

Requirements

• Experience in management of CROs, vendors and consultants and/or experience with Translational/Biomarker/Bioanalytical lab management
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines
• Adaptable and able to balance and manage multiple priorities
• Strong written and verbal communication skills and attention to detail
• Ability to collaborate effectively with cross-functional team members and external partners (including investigator and site staff)
• Strong computer skills including proficiency with Excel, Word, PowerPoint, Outlook
• Bachelor’s degree in health sciences or related field
• Minimum of 5+ years’ experience in clinical research with at least 3 years experience in study management

Responsibilities

• Provide comprehensive oversight of specialty lab vendors in partnership with Translational Biology, Immunology, and Genomics subject matter experts
• Partner with internal teams involved in conducting clinical sample testing to ensure communication and alignment on deliverables, sample tracking, and appropriate documentation
• In collaboration with Project Management and Clinical Operations, ensure vendors and internal teams are executing on analysis timelines and any risks are appropriately flagged and mitigated
• May participate in the Clinical Trial Team (CTT) and/or the program Clinical Sub Team
• Oversee direct reports, providing growth opportunities and training and ensuring alignment and harmonization on study management processes
• Contribute to and maintain updates of key metrics/KPIs associated with the Clinical Support function and vendors
• Ensures adherence to ICH/GCP/GLP/Federal and local regulations and company specific SOPs
• Develop, review and/or author documents including but not limited to: clinical trial protocols, lab manuals, clinical allocation and blinding protocols, regulatory submissions, training materials, SOPs
• Conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight
• Oversee specialty lab vendor budgets and agreements and provides financial reporting and forecasts to Finance and Accounting
• Requests and/or reviews scope of work agreements and budgets and escalates vendor performance issues as needed
• Assume leadership role in operational or process improvement initiatives (e.g. sample shipment tracking, consent verification process, ICF tracking, LIMS deployment)

Preferred Qualifications

• Global clinical trial management experience (Phase I-III) preferred
• Program-level experience preferred
• Rare disease experience preferred
• Line management experience preferred