Senior Clinical Trial Manager

Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat liver disease. Terns has assembled a broad pipeline of orally administered drug candidates for the treatment of non-alcoholic steatohepatitis (NASH).  Headquartered in Foster City, CA, Terns combines extensive research and development experience in drug development and experimental combination therapy with a capital-efficient drug discovery and clinical development model to advance its growing pipeline of medicines. 

Position Overview

The Senior/Clinical Trial Manager is accountable for leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of Clinical Trials in a matrix environment. This activity is typically coordinated in conjunction with one or more CROs. This position will report to a Associate Director of Clinical Operations. 

Responsibilities

• Manage all aspects of Clinical Trials to ensure trials are completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Lead Study Management Team Meetings
• Facilitate operational activities pertaining to the execution of Ph I-III Clinical Trials from study start through close-out
• Primary contact for functional area representatives and vendors responsible for protocol execution
• Management of CROs, service providers and consultants that are involved in assigned studies
• May assist in the development and review of study protocols, informed consent forms, case report forms, study plans, clinical study reports, study materials and tools
• Ensures accurate tracking and reporting of study progress
• Maintains study budgets and timelines
• Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs
• May conduct site visits (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities
• Participates in service provider selection process as a part of outsourcing activities
• Participates in selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
• Plan and coordinate Investigator Meetings

Requirements

• Bachelor’s degree, preferably in a scientific field
• A minimum of 2 years of Clinical Study Management experience at a Sponsor or CRO, preferably in NASH (or related)
• Excellent communication skills both verbal and written are required
• Flexibility and willingness to step in and be a team player
• Strong problem-solving skills with the ability to focus on time-sensitive objectives
• Thorough understanding of ICH GCP guidelines
• Understanding of Clinical Trial processes and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing)
• Self-motivated, assertive and able to function independently or as part of a team
• Effective in management of investigative sites, CROs, vendors, and external resources
• Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
• Proven problem solving and decision-making skills
• May have mentorship opportunities
• Ability and willingness to travel 10-20% (domestic and international)

The US base salary range for this full-time position is $145K to $175K + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.  

NOTE: This position summary is not intended to be all-inclusive. Employees may be required to perform other related duties as assigned to meet the organization's ongoing needs.  

Terns Pharmaceutical is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.