Senior Clinical Trial Manager - Ophthalmology

BioAge Labs

1d • $165,000 - $185,000 • Remote

About The Position

BioAge Labs is seeking an experienced Senior Clinical Trial Manager to lead its clinical trial programs in ophthalmology. This is a fully remote position, open to candidates in any of the continental US states. The Senior Clinical Trial Manager will provide 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.

Requirements

• 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 organizational, prioritization, and project management skills.
• Advanced proficiency in Microsoft Office, Smartsheets, Microsoft Excel, and clinical trial tracking and reporting tools.
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, clinical trial regulations, and inspection readiness expectations.
• Demonstrated ability to manage multiple complex studies, tasks, vendors, and competing priorities in a fast-paced, collaborative environment.
• Deep understanding of clinical systems used in studies, including EDC, eTMF, IWRS, lab portal systems, and related data flow processes.
• Advanced proficiency in Trial Master File (TMF) management, quality control, completeness, and inspection readiness.
• Hands-on experience overseeing clinical systems and clinical operations documentation, including eTMF, CTMS, EDC, study plans, trackers, and reports.
• Experience maintaining audit and regulatory inspection readiness across studies and vendors.
• Experience working in a small or early-stage biotech company, with flexibility to operate in a hands-on, resource-conscious environment.
• Experience working with global, regional, and/or multi-site clinical trials.
• Demonstrated CRO and vendor oversight experience, including performance management, anticipating and mitigating issues, and deliverable accountability.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• 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 workstreams 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.

Benefits

• Competitive salary
• Comprehensive compensation package
• Generous paid time off
• Company-observed holidays
• Comprehensive health and wellness benefits (medical, dental, and vision insurance)
• 401(k) retirement savings plan with matching employer contributions
• Childcare benefits
• Fertility benefits
• Opportunities for career development
• Generous annual budget for continued learning
• Dedication to training and skill development

What This Job Offers

• Job Type: Full-time
• Career Level: Senior