Full Job Description The Role:

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Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support clinical trials within our Clinical Development team. Reporting into Clinical Operations, this role will play a critical part in enabling high-quality execution of pivotal trials designed to support regulatory submissions and eventual product approval. The CTA will work cross-functionally with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection-readiness, ensure compliance with GCP standards, and support key trial deliverables. This is an exciting opportunity for someone who thrives in high-accountability environments and is eager to contribute to the final stages of clinical development with rigor and excellence. Here's how you will contribute: Support execution of Phase 1-3 clinical trials, including global site activation, study conduct, and closeout activities. Manage Trial Master File (TMF) setup, maintenance, and QC to ensure real-time, inspection- ready documentation. Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators (KPIs). Coordinate with internal teams and vendors to ensure trial activities align with the stringent regulatory requirements of Phase 1-3 trials. Assist in the collection and review of essential regulatory documentation required for trial initiation and maintenance. Organize study meetings, manage action and decision logs, and ensure high-quality documentation of operational progress. Track progress against timelines, escalate risks or delays, and contribute to mitigation planning. Support clinical audit readiness efforts, including document review, reconciliation, and regulatory filing preparation. Maintain informed consent and protocol amendment tracking across global trial sites. Assist in clinical vendor invoice reconciliation and budget tracking.

The Ideal Candidate will have:

Bachelor's degree; life sciences or related degree preferred 6 months to 1 year of experience supporting Phase 1-3 clinical trials at a sponsor or CRO. Proficient in clinical systems (eTMF, CTMS) and knowledgeable of FDA and ICH-GCP requirements for pivotal studies. Demonstrates strong organizational skills, problem solving, and effective communication Demonstrates understanding of the clinical drug development process, including study design, protocol objectives and operational impacts Ideal candidates will have understanding site management and monitoring practices, including importance of data quality/integrity, as well as fundamental understanding of protocol deviation identification and reporting Must be proficient in MS Office applications (word, excel, and PowerPoint at a minimum) to support study/program documentation and deliverables Basic understanding and importance of current ICH-GCP regulations/guidelines is required Enthusiastic, proactive, collaborative, and dependable Excited to learn and grow within the clinical operations team! Organized (with attention to detail) and able to problem solve Comfortable in a fast-paced environment and able to manage and prioritize competing tasks A preferred candidate has been identified for this role but all applicants will be considered. About Generate Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:

Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

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Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies :

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Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to

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Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of

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