Summary:

The Clinical Trial Manager will be responsible for the oversight, coordination, and execution of gene therapy clinical trials in support of Ascidian clinical programs in all phases of development. This is a tactical position and involves protocol execution at the site and project level through established vendor oversight and escalation pathways.

Job responsibilities:

• Works closely with the Associate Director and will be responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.
• Manage all operational aspects of assigned clinical trial(s)Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol.
• Independently manages assigned clinical studies.
• Monitor and track clinical trial progress and provide status updates to stakeholders and at project team meetings to senior management as needed.
• Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors, and collaboration with data management/statistics teams.
• Proactively identify potential issues/risks and recommend/implement solutions.
• Coordinates and/or participates in the development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study-related documents.
• Oversees and works directly with CROs, vendors, and all other partners. Establishes relationships with investigators, study coordinators, site personnel, and other external key stakeholders.
• Accountable for developing and managing study budgets and financial reporting, including month-end and quarterly reporting, financial reconciliation, accruals, and re‐forecasting, with Clinical, Finance, and Project Management
• Works with the Patient Recruitment/ Advocacy department and is responsible for the oversight of the recruitment strategy, enrollment projections, and meeting established targets.
• Presents at clinical team meetings and other forums on study progress.
• May travel to site visits, co-monitoring visits, Investigator Meetings, and conferences as applicable.

Job qualifications and requirements:

• Thorough understanding of FDA, ICH, and GCP guidelines
• Proven track record showing clear proficiency in clinical trial management skills
• Proven complex problem-solving skills collaboratively and independently
• Solid vendor management experience, e.g., CRO, laboratory, and /or clinical supply logistics
• Broad understanding of clinical operations related to the pharmaceutical drug development process
• Ability to effectively interface with personnel at clinical sites
• Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
• Excellent interpersonal, verbal, and written communication skills
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Education and experience:

• BA, BS in biological science, or degrees in nursing, pharmacy, medical technology, or other allied healthcare
• Minimum of 5 years of clinical trial management experience, at least 3 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotech
• Experience with Phase I - III clinical trials
• Proficiency with computer programs such as Google Suite & Microsoft Office