Clinical Trial Manager (Contract to Perm)

COMPANY INTRODUCTION

 

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine.  We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY 

The Clinical Trial Manager (CTM) will be responsible for the management of clinical trials from start-up to close-out. This position will manage the day-to-day operations of assigned clinical trials ensuring they are conducted in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company policies. The CTM will collaborate with cross-functional teams to ensure the trials are delivered on time, within budget, and to the highest quality standards.

On a day-to-day basis, you will be part of a high performing team and will be responsible for managing clinical trial operations for one or more studies while working closely with the Clinical Study Team.

The ideal candidate is an adaptable and resilient Clinical Trial Manager who is interested in working in a fast-paced, dynamic, collaborative biotech environment with a willingness and ability to contribute to the growth of the function and take on new challenges successfully. The candidate will work among a cross-functional Study Team from feasibility through study closeout. Prior experience in recruitment and retention tactics and site relationship management is a plus.

You must have experience managing phase 1/2 trials and be comfortable with executing all operational aspects of clinical trials inclusive of clinical vendor management. May be responsible for managing multiple clinical trials with varying levels of complexity.

This is a contract role with the potential to go permanent.

RESPONSIBILITIES 

Trial Management & Execution:

• Manage clinical trials, timelines, scope, budget, quality and vendor oversight.

• Create and maintain enrollment projections and propose/implement solutions to recruitment challenges and delays.
• Foster a collaborative team environment and maintain open communication channels with all internal and external stakeholders to ensure smooth trial execution.

• Contribute to protocol and clinical trial documentation development.
• Oversee the implementation of clinical trials at assigned study sites and ensure adherence to the protocol.

Site Management:

• Oversee/manage feasibility and site selection process.

• Build and maintain strong Investigator and site relationships.

• Provide ongoing support, guidance and training to investigators, clinical research coordinators, and study site teams.
• Ensure site adherence to regulatory and protocol requirements through regular communication and site visits as necessary.

Data Quality & Monitoring:

• Monitor trial progress, resolving any issues or deviations from the protocol or regulatory requirements.

• Collaborate with CRO and cross-functional team members to monitor clinical trial data, ensuring timely entry, collection, and identification of data quality issues escalating trends as appropriate.

Compliance & Regulatory Oversight:

• Ensure that clinical trial execution complies with all relevant regulatory requirements (e.g., GCP, FDA, ICH) and company SOPs.

• Ensure accurate documentation and regulatory compliance at all study sites.

• Ensure timely reporting of serious adverse events (SAEs) and other safety-related issues.

Vendor & CRO Management:

• Collaborate and develop relationships with external vendors and contract research organizations (CROs) to ensure they meet deliverables and comply with regulatory guidelines.
• Manage vendors such as central laboratories, central imaging and ECG, clinical outcome assessment vendors etc., to develop specifications, site training, provisioning of supplies, and tracking and resolution of issues in a timely manner.

Reporting & Documentation:

• Prepare and present regular reports on study status, including recruitment updates, site performance, data quality, and safety issues.
• Provide progress updates to senior management, highlighting any challenges or risks that may impact trial timelines or deliverables.
• Assist in development of SOPs and trial management processes.

EXPERIENCE & QUALIFICATIONS

• A minimum of 5 years of direct clinical trial experience with a solid understanding of functional area responsibilities associated with Clinical Operations.
• Good working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
• Must have strong problem-solving, communication and analytical skills.
• Experience in a fast-paced biotechnology environment highly preferred.
• Domestic and international travel up to 25% required.
• Ability to work on-site and adhere to an “office-first” culture is required.
• Prior experience in recruitment and retention tactics and site relationship management is a plus.