Clinical Trial Manager (or Senior)

BioAge; Northern (KY); Hybrid; USD 140,000 - 175,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive compensation

Comprehensive benefits

Job summary

BioAge Labs seeks a Clinical Trial Manager (Senior Manager) to lead planning, execution, and delivery of phase I–III studies across regional and global programs. You will oversee budgets, timelines, CROs, vendors, and inspection readiness, ensuring data integrity and regulatory compliance.

The role requires senior-level leadership across the study lifecycle, including start-up, enrollment, maintenance, and closeout, with proactive risk management and cross-functional collaboration.

Qualifications

• BA/BS in Health, Life Sciences, or related field required; advanced degree preferred.
• Minimum of 7 years of clinical operations or trial management.
• At least 5 years leading Phase I–III trials, global or multi-site.

Responsibilities

• Lead regional and global clinical trials with senior operations oversight.
• Manage study budgets, timelines, and CRO/vendor oversight.
• Ensure inspection readiness and regulatory compliance with GCP/ICH.

Skills

Clinical trial management

GCP/ICH knowledge

Cross-functional leadership

Study updates & reporting

Vendor oversight

Education

BA/BS in Health or Life Sciences

Advanced degree preferred

Tools

EDC

CTMS

TMF systems

Job description

BioAge Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan. https://bioagelabs.com

Position Summary:

Reporting to the VP of Clinical Operations, the Clinical Trial Manager (or Senior Manager) provides senior-level leadership for the planning, execution, oversight, and delivery of 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.
• 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.

Required Education & Experience

• BA/BS degree in Health, Life Sciences, or related field required; advanced degree preferred.
• 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.

Required Qualifications

• 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, Microsoft Project, 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, CTMS, 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, issue escalation, and deliverable accountability.

Our company

BioAge is a clinical-stage biopharmaceutical company harnessing the biology of human aging to develop new therapies for metabolic diseases. The Company’s human-first discovery platform analyzes proprietary multi-omics data captured over decades to identify molecular pathways that drive metabolic aging and disease. BioAge’s lead program, BGE-102, is a potent, orally available, brain-penetrant NLRP3 inhibitor being developed for diseases driven by inflammation. The Company is also advancing oral and injectable APJ agonists—exercise mimetics with the potential to enhance incretin-driven weight loss and restore healthy body composition in obesity. BioAge’s discovery platform is validated by ongoing research collaborations with Novartis and Lilly. BioAge has been listed on Nasdaq (BIOA) since 2024. For additional information about BioAge, visit the company’s website at https://bioagelabs.com.

Benefits

• BioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays.
• We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits.
• We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development.
• Many positions (including this one) are remote, allowing our team members to work from anywhere.
• The salary for this role is expected to be approximately $140,000 - $175,000, depending on experience.
• We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.

At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.