Clinical Trial Associate

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support Phase 3 clinical trials within our Clinical Development team. Reporting to the Sr. Director of Late Stage 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 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 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

· 2+ years of experience supporting Phase 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

· Travel is required as needed, however minimal (no more than 10-20% for monitoring related work)

 

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orien