Clinical Trial Associate

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. 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)

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.

Generate: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: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate: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 Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.