Senior Clinical Trial Associate

Cogent Biosciences • Waltham, MA

4d

About The Position

The Senior Clinical Trial Associate supports the planning, execution, and closeout of clinical trials at Cogent Biosciences, working closely with Clinical Trial Managers and cross-functional study teams. The role supports CRO and vendor oversight, study documentation, quality, and inspection readiness, with increasing ownership of assigned workstreams and responsibility for driving follow-up to ensure timely completion of deliverables. It is a hands-on Clinical Operations role within a growing biotechnology company.

The position contributes to management of one or more trials, acts as an operational point of contact for internal and external study personnel, and supports site management, study records, vendor oversight, study documentation, quality control, site payments, monitoring, audit preparation, and inspection readiness. It also contributes operational input to core study documents and helps prepare study and departmental presentations.

Requirements

• Bachelor’s degree.
• At least 3 years of clinical research experience.
• Working knowledge of ICH GCP and its application to clinical trial documentation and operations.
• Strong organizational skills and attention to detail, with the ability to maintain accurate records and manage competing priorities and deadlines.
• Ability to take ownership of assigned tasks, proactively follow up, and drive action items to completion.
• Strong written and verbal communication skills.
• Ability to work effectively on multiple cross-functional teams with increasing independence, incorporate feedback, and seek guidance when needed.
• Proficiency with Microsoft Office.
• Experience using SharePoint or OneDrive to manage shared documents and coordinate review.

Nice To Haves

• Experience supporting sponsor or CRO clinical operations.

Responsibilities

• Contribute to the management of one or more clinical trials, supporting planning, execution, and closeout with increasing autonomy and ownership of assigned workstreams.
• Serve as an operational point of contact for internal and assigned external study personnel, including investigative sites and vendors, ensuring clear communication and proactive follow-up.
• Support Sponsor oversight of site management activities, including reviewing monitoring reports, tracking site visits, and identifying or escalating site-level issues and trends.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
• Maintain and enhance sponsor-owned study trackers, tools, and dashboards; review CRO-maintained trackers and reports for accuracy, completeness, and timeliness; coordinate discrepancy resolution and identify process and reporting improvements.
• Maintain sponsor-owned study records and support oversight of CRO-maintained CTMS and TMF records, including ongoing TMF quality reviews and reconciliation, identifying gaps and coordinating their resolution with the Clinical Trial Manager.
• Support vendor oversight by reviewing status reports, tracking contracted deliverables, timelines, performance, and documentation, and following up on outstanding action items.
• Support vendor selection and contracting, including scope-of-work reviews and contract routing.
• Identify, troubleshoot, and communicate quality and compliance risks, and support implementation of corrective actions.
• Perform quality control review of study documents and support operational aspects of site payments.
• Contribute to the development, review, and maintenance of study operational plans and documents; coordinate collaborative review, track reviewer feedback, consolidate comments, and maintain version control.
• Participate in review of core study documents, including protocols, Investigator’s Brochures, and clinical study reports, and provide operational input.
• Participate in cross-functional project team meetings; capture key decisions, action items, and risks, and drive follow-up.
• Support development of study and departmental presentations and increasingly contribute to content development.
• Assist with site monitoring activities, audit and inspection preparation, and inspection readiness activities.

Benefits

• Competitive salary, bonus, and ongoing stock awards.
• Medical, dental, and vision premiums covered at 100% for employees and their families.
• Funding for up to 75% of in-network deductibles.
• 401(k) match with immediate vesting.
• Generous paid time off.
• 12 weeks of fully paid parental leave.
• Paid family and medical leave for all employees regardless of location.
• Company-paid short-term disability coverage for up to 20 weeks.
• Wellness programs.
• Tuition reimbursement.
• Inclusive family-forming support.
• Free on-site parking and building gym facilities at the Waltham location.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior