Senior Clinical Trial Manager - Ophthalmology
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-09-23
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Healthcare
Clinical Research
Bio Age Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan.
We are seeking an experienced Senior Clinical Trial Manager to lead our clinical trial programs in ophthalmology. This is a fully remote position, and the successful candidate can live in any of the continental US states.
Position Summary:Reporting to the VP of Clinical Operations, the Senior Clinical Trial Manager provides senior-level leadership for the planning, execution, oversight, and delivery of ophthalmology related clinical studies across Phase I/Ib/II/III programs. This role independently leads complex regional and global clinical trials, drives operational strategy, manages study budgets and timelines, provides oversight of CROs and vendors, and ensures inspection readiness and compliance with GCP, ICH, protocol, and regulatory requirements.
Job Duties:- Independently leads and manages Phase I/Ib/II/III clinical studies of moderate to high complexity, including large regional and/or global trials.
- Provides senior clinical operations leadership across the study lifecycle, including study start-up, enrollment, maintenance, closeout, and inspection readiness activities.
- Drives execution of study operational plans, timelines, budgets, risk mitigation strategies, communication plans, monitoring plans, and vendor oversight plans to ensure timelines are met.
- Serves as the primary operational lead for assigned studies and may lead clinical operations work streams within larger development programs.
- Leads cross-functional study teams, facilitates effective decision-making, and ensures alignment across internal stakeholders, CROs, contractors, vendors, and clinical research sites.
- Provides primary CRO and vendor oversight, including performance management, issue escalation, deliverable review, and accountability for quality, budget, and timelines.
- Contributes to the development, review, and implementation of clinical plans, study budgets, study timelines, and operational feasibility assessments.
- Identifies, assesses, and escalates study risks and implements proactive contingency and mitigation strategies to support successful trial delivery.
- Oversees clinical systems, including EDC, CTMS, eTMF, IWRS, and lab portals, ensuring data integrity, quality control, timely updates, and accurate study status reporting.
- Maintains TMF quality, completeness, and inspection readiness in partnership with internal teams, CROs, and vendors.
- Prepares and communicates regular study updates, milestone reports, dashboards, and performance metrics to internal and external stakeholders.
- Supports and oversees study data review, data cleaning, query resolution, and database lock activities by clearly communicating expectations and timelines.
- Maintains proactive interaction with clinical research sites and provides field-based monitoring or site management support as required.
- Manages study correspondence, documentation, and files to support high-quality study execution and audit readiness.
- May mentor or provide guidance to junior clinical operations staff, contractors, or study team members.
- Able and willing to Travel to study sites to build site relationships and knowledgeable in the operational conduct and oversight of ophthalmic studies
- BA/BS degree in Health, Life Sciences, or related field required; advanced degree preferred.
- Experience overseeing clinical trials related to ophthalmic indications
- Minimum of 7 years of clinical operations or clinical trial management experience, or demonstration of equivalent capability.
- At least 5 years of clinical research and development experience with a proven track record of independently managing clinical trials.
- Prior experience leading or substantially overseeing Phase I/Ib/II/III clinical trials, including complex, global, regional, or multi-site studies.
- Experience managing CROs, vendors, study budgets, timelines, and cross-functional study team deliverables required.
- Exceptional communication, interpersonal, leadership, and influencing skills with the ability to lead cross-functional teams and external partners.
- Strong written and verbal communication skills, including the ability to prepare concise study updates, escalation summaries, and operational reports.
- Highly reliable, self-motivated, solutions-oriented team player with sound judgment and accountability for study outcomes.
- Detail-oriented with advanced…
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