Clinical Trial Manager

Role Summary

Clinical Trial Manager (CTM) to join the Clinical Operations team, serving as the operational lead to drive timelines, foster collaboration, and ensure successful execution of clinical trials. Oversees day-to-day activities throughout the trial lifecycle, managing start-up, conduct, and close-out activities in alignment with ICH/GCP guidelines.

Responsibilities

• Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities.
• Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals.
• Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO to manage the daily operational management activities of CROs and study vendors.
• Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities.
• Contribute to (or oversee the management of) the creation of the trial plans and site facing documents.
• Develop (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members.
• Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
• Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
• Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate.
• Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study.
• Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial.

Qualifications

• Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials.
• Phase I experience is strongly preferred; a background in rare disease and/or metabolic disorders is highly desirable, and experience with cell & gene therapy is a plus.
• Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes.
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
• Ability and willingness to travel up to 20% (domestic and international).