Clinical Trials Associate (or Senior)

BioAge Labs; United States; Remote; USD 80,000 - 90,000; Full time

Job summary

BioAge Labs seeks a Clinical Trial Associate (Senior CTA) to join our Clinical Operations team. The role supports Phase 1–3 trials, ensuring TMF quality, inspection readiness, and compliance with ICH/GCP and SOPs, in collaboration with CTMs, CROs, vendors, and investigative sites.

The CTA will maintain accurate data in eTMF/CTMS/EDC, assist with protocol and consent form development, and help coordinate IRB/IEC submissions and regulatory documents.

Qualifications

• Bachelor's degree in a scientific or healthcare field, or equivalent experience.
• 2–3+ years of clinical operations experience in biotech, pharmaceutical, or CRO settings.
• Experience supporting Phase 1–3 clinical trials.
• Hands-on TMF management with eTMF, CTMS, and EDC.
• Working knowledge of ICH/GCP and regulatory requirements.
• Strong organizational skills and exceptional attention to detail.
• Ability to manage multiple priorities in a fast-paced, collaborative environment.
• Excellent written and verbal communication skills.

Responsibilities

• Independently support and coordinate clinical trial activities from start-up through close-out.
• Partner with CTMs to ensure milestones, timelines, and deliverables.
• Serve as primary owner of TMF quality, completeness, and inspection readiness.
• Perform TMF quality control and resolve documentation gaps with internal teams and vendors.
• Collaborate with CROs, vendors, and sites to ensure study milestones and deliverables are met.
• Track study timelines, identify risks, and escalate issues as needed.
• Support IRB/IEC submissions and review regulatory documents for compliance.
• Maintain data in clinical systems (eTMF, CTMS, EDC).
• Assist with development and review of protocols, informed consent forms and study manuals.
• Support preparation and tracking of IRB/IEC submissions and regulatory documentation.
• Coordinate and track laboratory samples from sites to labs, ensuring timely shipment and documentation accuracy.
• Participate in meetings, prepare agendas, minutes, and action items.
• Prepare and manage study communications, including newsletters and study updates.
• Contribute to audit and inspection preparation activities.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Education

Bachelor's degree in scientific/healthcare field

Tools

eTMF

CTMS

EDC

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

Clinical Trial Associate (or Senior)

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

BioAge is seeking a Clinical Trial Associate (Senior CTA) to join our Clinical Operations team.

Position Summary

The CTA plays a critical role in the execution of Phase 1–3 clinical trials and is responsible for ensuring operational excellence, inspection readiness, and compliance with ICH/GCP guidelines and company SOPs. This position partners closely with Clinical Trial Managers, CROs, vendors, and investigative sites to support timely and high-quality study delivery.

Key Responsibilities

• Independently support and coordinate clinical trial activities from start-up through close-out.
• Partner with CTMs to ensure operational milestones, timelines, and deliverables are achieved.
• Serve as primary owner of Trial Master File (TMF) quality, completeness, and inspection readiness.
• Perform ongoing TMF quality control and resolve documentation gaps with internal teams and vendors.
• Collaborate with CROs, vendors, and sites to ensure study milestones and deliverables are met.
• Track study timelines, identify risks, and proactively escalates issues as needed.
• Support IRB/IEC submissions and review essential regulatory documents for compliance.
• Maintain accurate and timely data within clinical systems (eTMF, CTMS, EDC).
• Assist with development and review of key clinical documents, including protocols, informed consent forms and study plans/manuals.
• Support preparation, review, and tracking of IRB/IEC submissions and regulatory documentation.
• Coordinate and track laboratory samples from investigative sites to central and specialty laboratories, ensuring timely shipment, reconciliation, and documentation accuracy.
• Participate in internal and external meetings, including preparation of agendas, meeting minutes, and action item tracking.
• Prepare and manage study communications, including newsletters and study updates as needed.
• Contribute to audit and inspection preparation activities.

Qualifications and Required Skills

• Bachelor's degree in a scientific or healthcare-related field preferred; equivalent experience considered.
• 2-3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings.
• Experience supporting Phase 1–3 clinical trials.
• Hands-on experience with TMF management and clinical systems (eTMF, CTMS, EDC).
• Working knowledge of ICH/GCP and applicable regulatory requirements.
• Strong organizational skills and exceptional attention to detail.
• Ability to manage multiple priorities in a fast-paced, collaborative environment.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience in a small or early-stage biotech company.
• Experience supporting audit or regulatory inspection readiness.
• Experience working with global or multi-site clinical trials.

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 cardiovascular risk and retinal diseases. 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 .

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 $80,000 - 90,000, 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.