Clinical Trial Manager (CTM)

The Clinical Trial Manager (CTM) is accountable for coordinating and driving a broad set of operational activities for one or more clinical studies or defined workstreams, under the leadership of the designated Study Lead. This individual contributor role may serve as the primary point of contact for assigned studies and provide coordination across internal cross-functional teams and external vendors to ensure studies are delivered on time, within budget, and in compliance with regulatory requirements and company policies.

The CTM will support the clinical development of BBP-418 for LGMD2I/R9 Muscular Dystrophy and potentially additional indications. The ideal candidate thrives in a dynamic biotech environment, demonstrates strong problem-solving skills, anticipates risks, and maintains a high standard of quality and inspection readiness.

The CTM must conduct all work activities in compliance with applicable laws, regulations, ICH-GCP guidelines, and company policies and procedures.  Responsibilities may include but are not limited to what is indicated below.

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  Coordinate and drive operational activities across assigned study workstreams (e.g., start-up, enrollment, monitoring, database lock, close-out), working under the Study Lead.

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  Maintain and update study trackers, timelines, and deliverable logs; proactively escalate timeline risks and propose mitigation plans.

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  Manage CROs and external vendors across all phases of study start-up, conduct, and close-out, ensuring deliverables are on time, within budget, and fully compliant with GCP, SOPs, and regulatory requirements.

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  Provide oversight of clinical monitoring activities, including review of monitoring visit reports and conduct monitoring oversight visits to confirm adherence to study protocols and quality standards.

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  Participate in cross-functional and vendor operational meetings as required; document decisions and action items.

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  Oversee site-level operational activities such as specimen management, subject visit tracking, and timely data review to identify trends, discrepancies, and potential risks.

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  Contribute to site feasibility, selection, and initiation activities while supporting the development and approval of essential study documents, including monitoring plans, ICFs, CRFs, pharmacy, and laboratory manuals.

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  Oversee study supply management, review site and study budgets, and evaluate CRO/vendor invoices to ensure financial accountability and transparency.

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  Ensure the Trial Master File is current, accurate, and inspection-ready.

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  Participate in Investigator Meetings

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  Support protocol and study report development

This is a U.S-based remote role that will require quarterly, or as needed visits, to our San Francisco Office. Travel to study sites may also be required.

• BA/BS in life sciences, nursing, or related field (or equivalent work experience).

• At least 5 years of progressive experience in clinical operations, clinical research, or a CRO/pharma environment.

• Direct experience with site management, monitoring, or clinical operations duties (site visit experience required).

• Hands-on experience with eTMF systems and clinical data systems (EDC), and competency in common study tracking tools (Excel, Smartsheet, etc.).

• Working knowledge of ICH-GCP and applicable regulatory requirements (FDA/EMA).

• Strong organizational skills, attention to detail, and the ability to manage competing priorities.

• Excellent interpersonal and written/verbal communication skills; comfortable coordinating across functional teams.