Senior Clinical Trials Lead — Global Ops & Vendor Oversight

Definium Therapeutics; Durham (NC); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Flexible time off

Parental leave

Job summary

Definium Therapeutics in the United States is seeking a Senior CTM to lead site- and country-level trial logistics within the Clinical Operations Department. You will oversee external vendors, ensure data integrity, timelines, and budget adherence across late-phase studies.

The role emphasizes trial lead responsibilities from protocol synopsis to CSR, inspection readiness, training, and collaboration with QA, study clinicians, and cross-functional teams in a fast-paced biopharma environment.

Qualifications

• BS degree or equivalent in Life Sciences; preferred fields include Biology, Chemistry, Biochemistry, Nursing, Pharmacy
• Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
• Experience managing clinical trials or senior CRA role, ideally in the psychiatric space
• Willingness and ability to travel up to 20% of the time
• Strong organizational skills and ability to work in a fast-paced environment
• Experience in vendor management is strongly preferred
• Excellent leadership and team-building abilities

Responsibilities

• Review Monitoring Visit Reports and scheduling to ensure data quality
• Serve as Sponsor contact for external service providers/vendors
• Oversee CRO/Vendor partners to meet timelines and budgets
• Maintain therapeutic knowledge of study protocols
• Collaborate with CROs to revise scope, budgets, and timelines
• Oversee CRO monitoring team activities and deliverables
• Assist QA with site audits
• Review study protocols, eCRF design, and SOPs
• Manage site contracts, budgets, and CRO invoices
• Coordinate trial materials and site recruitment meetings
• Lead development and implementation of SOPs and systems
• Ensure inspection-readiness and training for trial staff
• Ensure selection, setup, and oversight of external vendors

Skills

Clinical trial experience

Education

BS degree or equivalent

Job description

Definium Therapeutics in the United States is seeking a Senior CTM to lead site- and country-level trial logistics within the Clinical Operations Department. You will oversee external vendors, ensure data integrity, timelines, and budget adherence across late-phase studies.

The role emphasizes trial lead responsibilities from protocol synopsis to CSR, inspection readiness, training, and collaboration with QA, study clinicians, and cross-functional teams in a fast-paced biopharma environment.