Clinical Trial Manager (Contract to Perm)

Triveni Bio•Watertown, MA

1d•$70 - $76•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 CTM works closely with the Clinical Study Team and cross-functional partners to deliver studies on time, within budget, and to high quality standards. The role may oversee multiple studies with varying levels of complexity and requires experience managing Phase 1/2 trials, including clinical vendor management. This is a contract role with the potential to become permanent. The successful candidate will be adaptable and resilient, and interested in contributing to a fast-paced, dynamic, collaborative biotech environment. The CTM participates in cross-functional Study Teams from feasibility through closeout. Recruitment and retention tactics and site relationship management experience are a plus. The position requires working on-site in an office-first culture and domestic and international travel of up to 25%. Compensation is $70–$76 per hour; actual compensation depends on factors including skills, experience, education, certifications, qualifications, market demand, and geographic location.

Requirements

At least 5 years of direct clinical trial experience, with a solid understanding of Clinical Operations functional area responsibilities.
Experience managing Phase 1/2 clinical trials.
Comfort executing all operational aspects of clinical trials, including clinical vendor management.
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 develop and implement solutions to recruitment challenges and delays.
Promote collaboration and maintain open communication with internal and external stakeholders.
Contribute to protocol and clinical trial documentation development.
Oversee trial implementation at assigned sites and ensure adherence to the protocol.
Oversee or 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 study site teams.
Ensure sites adhere to regulatory and protocol requirements through regular communication and site visits as needed.
Monitor trial progress and resolve issues or deviations from protocol or regulatory requirements.
Work with CRO and cross-functional team members to monitor trial 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 and ensure they meet deliverables and regulatory requirements.
Manage vendors such as central laboratories, central imaging and ECG, and clinical outcome assessment vendors, including specifications, site training, supply provisioning, and timely issue tracking and resolution.
Prepare and present study status reports covering recruitment, site performance, data quality, and safety issues.
Provide progress updates to senior management, highlighting challenges or risks that may affect timelines or deliverables.
Assist in developing SOPs and trial management processes.