Senior Clinical Trial Manager

Definium Therapeutics

17d • $160,000 - $190,000

About The Position

The Senior Clinical Trial Manager (Senior CTM) works within Definium Therapeutics’ Clinical Operations Department, providing site- and/or country-level management and oversight of vendors and external service providers. The role may be assigned as the Clinical Operational Trial Lead, with oversight from the Senior Director or Executive Director of Clinical Operations. It is responsible for ensuring high-quality deliverables are completed within agreed timelines and budgets and in accordance with applicable SOPs and regulatory requirements.

When assigned as Clinical Operational Trial Lead, the Senior CTM is accountable for cross-functional trial delivery from draft protocol synopsis through availability of the Clinical Study Report and applicable disclosure of trial results. Whether managing sites, countries, and vendors or leading trial operations, the role supports inspection readiness, data integrity, and data quality in compliance with corporate and project/program SOPs, GCP/ICH guidelines, and applicable federal and state regulations.

The role also contributes to the development and review of Clinical Operations SOPs, plans, and systems; leads process-improvement initiatives; and develops processes and site/trial management tools. For outsourced trials, the Senior CTM serves as a key liaison responsible for oversight and delivery of transferred obligations and responsibilities. The position requires travel up to 20% based on business needs. The starting base pay range is $160,000–$190,000 USD. Employees may also be eligible for bonus and equity.

Requirements

• BS degree or equivalent required; preferably in a life-sciences field such as Biology, Chemistry, Biochemistry, Nursing, or Pharmacy.
• At least 6 years of clinical trial experience in the pharmaceutical industry or at a CRO.
• Experience managing clinical trials or prior experience in a senior CRA role; experience in the psychiatric space is ideal.
• Willingness and ability to travel up to 20% based on business needs.
• Strong organizational skills and attention to detail, with the ability to work effectively in a fast-paced, dynamic environment.
• Clinical research operational knowledge and project planning/management, communication, and presentation skills.
• Ability to manage all aspects of clinical trial execution.
• Experience managing teams in a virtual environment.
• Excellent leadership skills and a demonstrated ability to foster team productivity and cohesiveness.

Nice To Haves

• Experience in vendor management is strongly preferred.
• Experience in the psychiatric therapeutic area is ideal.

Responsibilities

• Use Definium or CRO systems to review Monitoring Visit Reports, monitoring visit schedules and metrics, protocol deviations, issues, and action items to support data quality.
• Serve as the sponsor contact for external service providers and vendors, ensuring high-quality delivery within timelines and budget.
• Oversee and track CRO and vendor partners to ensure patient enrollment and data collection meet study timelines and objectives; escalate timeline and budget risks as needed.
• Maintain therapeutic knowledge and familiarity with clinical protocols and projects.
• Work with CROs and vendors to revise service scopes, budgets, plans, and detailed timelines, and ensure performance expectations are met.
• Oversee CRO monitoring team activities and deliverables.
• Assist Quality Assurance with site audits.
• Review and contribute to study protocols, eCRF design changes, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study documents and plans.
• Manage trial finances, including reviewing and approving site contracts and budgets, CRO/vendor invoices, and accruals, with oversight from the Senior Director of Clinical Operations.
• Assist with tracking and coordinating trial materials, including investigational product and clinical trial and laboratory samples.
• Organize and manage site round-table and site recruitment meetings.
• Participate in the development, review, and implementation of departmental SOPs, systems, and processes.
• Oversee external service providers for in-house and outsourced trials, including their selection and setup, and ensure scopes of work and specifications align with protocol requirements, budgets, and timelines.
• Keep the trial team in a state of inspection readiness and collaborate with Quality liaisons on quality oversight using available tools.
• Ensure trial team members receive appropriate trial-specific training for their functions; collaborate with the study clinician on training for team members and/or the CRO.
• When assigned as Clinical Operational Trial Lead, ensure successful cross-functional trial delivery from draft protocol synopsis through CSR availability and applicable results disclosure.

Benefits

• 100% paid medical, dental, and vision benefits for employees and their dependents.
• 401(k) program with company match and vesting after the turn of the first month after the start date.
• Flexible time off.
• Generous parental leave.
• Additional fringe perks.
• Potential eligibility for bonus and equity.

What This Job Offers

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