Clinical Trial Manager (Contract to Perm)

Triveni Bio•Watertown, MA

3d•Onsite

About The Position

The Clinical Trial Manager (CTM) manages clinical trials from start-up through close-out, overseeing day-to-day operations to ensure compliance with Good Clinical Practice (GCP), regulatory guidelines, and company policies. The role collaborates with cross-functional teams to deliver trials on time, within budget, and to high quality standards. The CTM works with the Clinical Study Team and may manage one or more studies with varying levels of complexity, contributing across the study lifecycle from feasibility through closeout. The position requires experience managing Phase 1/2 trials and clinical vendor operations. It is a contract role with the potential to become permanent, in a fast-paced, collaborative biotech environment. The role requires an office-first, on-site work arrangement and domestic and international travel of up to 25%.

Requirements

At least 5 years of direct clinical trial experience.
Experience managing Phase 1/2 trials.
Solid understanding of functional-area responsibilities associated with Clinical Operations.
Good working knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management.
Strong problem-solving, communication, and analytical skills.
Ability to work on-site and adhere to an office-first culture.
Ability to travel domestically and internationally up to 25%.

Nice To Haves

Experience in a fast-paced biotechnology environment.
Experience with recruitment and retention tactics and site relationship management.

Responsibilities

Manage clinical trial timelines, scope, budget, quality, and vendor oversight.
Create and maintain enrollment projections and propose and implement solutions to recruitment challenges and delays.
Maintain open communication with internal and external stakeholders and foster a collaborative team environment.
Contribute to protocol and clinical trial documentation development.
Oversee trial implementation at assigned sites and ensure adherence to the protocol.
Manage feasibility and site selection.
Build and maintain relationships with investigators and study sites.
Provide support, guidance, and training to investigators, clinical research coordinators, and site teams.
Support site compliance with regulatory and protocol requirements through regular communication and site visits as necessary.
Monitor trial progress and resolve protocol deviations and other issues involving regulatory requirements.
Work with CROs and cross-functional team members to monitor data, support timely data entry and collection, identify data quality issues, and escalate trends as appropriate.
Ensure trial execution complies with GCP, FDA and ICH requirements, and company SOPs.
Ensure accurate documentation and regulatory compliance at study sites.
Ensure timely reporting of serious adverse events and other safety-related issues.
Manage relationships with external vendors and CROs, ensuring delivery of commitments and compliance with regulatory guidelines.
Manage vendors such as central laboratories, central imaging and ECG providers, and clinical outcome assessment vendors, including specifications, site training, supply provisioning, and timely issue tracking and resolution.
Prepare and present regular reports on study status, recruitment, site performance, data quality, and safety issues.
Update senior management on progress, challenges, and risks affecting trial timelines or deliverables.
Assist with developing SOPs and trial management processes.