Senior Clinical Trial Manager

$166,000 - $182,000/Yr

Assembly Biosciences - San Francisco, CA

Full-time - Senior

San Francisco, CA

11-50 employees

Professional, Scientific, and Technical Services

About the position

The Senior Clinical Trial Manager will lead and manage all operational aspects of clinical trials from startup through closedown at Assembly Bio, a small biotechnology organization. This role requires expertise in ensuring compliance with regulations and guidelines, managing cross-functional teams, and overseeing study vendors. The position offers flexibility for remote work but requires routine on-site meetings in South San Francisco, CA.

Responsibilities

• Assume the Clinical Study Lead role to manage all operational aspects of clinical trials from study start-up through clinical study report finalization.
• Lead the Study Management Team (SMT) and manage the cross-functional team in a matrix environment.
• Anticipate potential study issues and implement ongoing risk identification and mitigation plans.
• Ensure significant issues affecting timeline, budget, or resourcing are escalated appropriately.
• Oversee or direct the development of key study documents including Protocol, ICFs, CSRs, and study-specific plans.
• Create and maintain study level timeline and budget, tracking actuals during study conduct.
• Review and approve study work orders, change orders, and invoices.
• Oversee or direct study-specific training needs for the SMT and CRO, preparing training materials for Investigators and site staff.
• Manage the study vendor selection process including requests for proposals, budget negotiation, and work order setup.
• Oversee the setup, maintenance, and closedown of study systems such as Central Lab and IRT.
• Maintain frequent contact with CRO and study vendors.
• Oversee the TMF throughout the study and participate in periodic QC.
• Confirm documents for TMF, timelines, recipients, and distribution processes.
• Direct the selection of investigative sites and approve site budget templates, negotiating site budgets and payments.
• Ensure oversight of monitoring activities to protect subject safety and ensure compliance with regulatory requirements.
• Lead the review of protocol deviations and follow-up in collaboration with CRO and study team.
• Assess the impact of amendments and lead associated changes to study timelines, budget, vendor responsibilities, and systems.
• Assist with the review of CRF design and ensure queries are resolved.
• Collaborate with Clinical Development to ensure patient safety and with Clinical Supplies to maintain adequate IP supplies.
• Collaborate with Regulatory Affairs for compliance and with Quality Assurance to address quality events and ensure audit readiness.
• Prepare details for initial public trial registration and ensure changes are reviewed and submitted.

Requirements

• Bachelor's degree with 7-9 years or master's degree with 5+ years of Clinical Operations experience in the pharmaceutical/biotechnology industry.
• Thorough knowledge of ICH/GCP guidelines.
• Experience in the Clinical Study Lead role from start-up through closedown.
• Demonstrated successful collaboration with other functional area representatives.
• Experience managing vendors independently, including Central Lab, IRT, and CRO vendors.
• Strong communication skills to ensure transparency in clinical study plans and risks.
• Ability to interpret study level data and identify risks and mitigations.
• Demonstrated leadership and interpersonal skills to hire, develop, and retain employees.
• A collaborative and flexible leadership style to manage a diverse team.
• Excellent written and oral communication skills.
• Willingness to embrace change and work in a changing environment.
• Ability to work collaboratively across geographies.
• Proficiency in Microsoft Word, Project, PowerPoint, Excel, SharePoint.

Benefits

• Competitive salary range of $166,000 - $182,000 based on experience and location.
• Flexible work environment with remote work options.
• Opportunities for professional development and growth within the company.