Role Description
BioAge is seeking a Senior Clinical Trial Associate (Senior CTA) to join our Clinical Operations team.
The Senior CTA plays a critical role in the execution of Phase 1β3 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
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Independently support and coordinate clinical trial activities from start-up through close-out.
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Partner with CTMs to ensure operational milestones, timelines, and deliverables are achieved.
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Serve as primary owner of Trial Master File (TMF) quality, completeness, and inspection readiness.
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Perform ongoing TMF quality control and resolve documentation gaps with internal teams and vendors.
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Collaborate with CROs, vendors, and sites to ensure study milestones and deliverables are met.
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Track study timelines, identify risks, and proactively escalate issues as needed.
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Support IRB/IEC submissions and review essential regulatory documents for compliance.
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Maintain accurate and timely data within clinical systems (eTMF, CTMS, EDC).
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Assist with development and review of key clinical documents, including protocols, informed consent forms and study plans/manuals.
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Support preparation, review, and tracking of IRB/IEC submissions and regulatory documentation.
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Coordinate and track laboratory samples from investigative sites to central and specialty laboratories, ensuring timely shipment, reconciliation, and documentation accuracy.
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Participate in internal and external meetings, including preparation of agendas, meeting minutes, and action item tracking.
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Prepare and manage study communications, including newsletters and study updates as needed.
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Contribute to audit and inspection preparation activities.
Qualifications
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Bachelorβs degree in a scientific or healthcare-related field preferred; equivalent experience considered.
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2-3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings.
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Experience supporting Phase 1β3 clinical trials.
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Hands-on experience with TMF management and clinical systems (eTMF, CTMS, EDC).
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Working knowledge of ICH/GCP and applicable regulatory requirements.
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Strong organizational skills and exceptional attention to detail.
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Ability to manage multiple priorities in a fast-paced, collaborative environment.
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Excellent written and verbal communication skills.
Requirements
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Experience in a small or early-stage biotech company.
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Experience supporting audit or regulatory inspection readiness.
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Experience working with global or multi-site clinical trials.
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Prior CRO oversight experience.
Benefits
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Competitive salary and comprehensive compensation package.
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Generous paid time off in addition to company-observed holidays.
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Comprehensive health and wellness benefits (medical, dental, and vision insurance).
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401(k) retirement savings plan with matching employer contributions.
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Childcare and fertility benefits.
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Opportunities for career development, including a generous annual budget for continued learning.
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Many positions are remote, allowing team members to work from anywhere.
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Salary for this role is expected to be approximately $90,000, depending on experience.