Clinical Trial Associate

The Role:

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical TrialAssociate to support clinical trials within our Clinical Development team. Reporting into ClinicalOperations this role will play a critical part in enabling high-quality execution of pivotal trialsdesigned to support regulatory submissions and eventual product approval. The CTA will workcross-functionally with Clinical Supply Data Management Regulatory QA and CROs tomaintain inspection-readiness ensure compliance with GCP standards and support key trialdeliverables.

This is an exciting opportunity for someone who thrives in high-accountability environments andis eager to contribute to the final stages of clinical development with rigor and excellence.

Heres how you will contribute:

Support execution of Phase 1-3 clinical trials including global site activation study conductand 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 keyperformance 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 trialinitiation and maintenance.
Organize study meetings manage action and decision logs and ensure high-qualitydocumentation 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 andregulatory 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:

Bachelors 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-GCPrequirements for pivotal studies.
Demonstrates strong organizational skills problem solving and effective communication
Demonstrates understanding of the clinical drug development process including study designprotocol objectives and operational impacts
Ideal candidates will have understanding site management and monitoring practices includingimportance of data quality/integrity as well as fundamental understanding of protocol deviationidentification and reporting
Must be proficient in MS Office applications (word excel and PowerPoint at a minimum) tosupport 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 creationone 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 Companys 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.