Senior Clinical Trial Manager

The role

The Senior CTM provides site, country, or vendor level management within the Clinical Operations Department. This role may act as the Clinical Operational Trial Lead to ensure cross-functional delivery from protocol synopsis to Clinical Study Report.

What you will do

• Review monitoring visit reports, scheduling, metrics, protocol deviations, and action items
• Serve as Sponsor contact for external service providers to ensure high quality deliverables
• Oversee CRO/Vendor partners to ensure patient enrollment and data collection meet timelines
• Work with CRO/Vendors to revise scope of service agreements, budgets, plans, and timelines
• Oversee CRO monitoring team activities and deliverables
• Assist QA with site audits
• Review and contribute to study protocols, eCRF design, manuals, and informed consent forms
• Perform financial management including site contracts, budgets, and CRO/Vendor invoices
• Assist in tracking and coordination of trial related materials
• Organize and manage site round-table and recruitment meetings

Required qualifications

• BS degree or equivalent
• Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
• Experience with managing clinical trials or prior experience in a senior CRA role
• Willingness and ability to travel up to 20% of the time
• Strong organizational skills and attention to detail
• Clinical research operational knowledge
• Project planning/management skills
• Communication and presentation skills
• Ability to manage all aspects of execution of a clinical trial
• Experience managing teams in a virtual environment
• Excellent leadership skills

Nice to have

• Degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Experience in the psychiatric space
• Experience in vendor management

Benefits

• Health insurance
• 401(k) with company match
• Flexible time off
• Additional wellness benefits and perks

About the company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics for psychiatric and neurological disorders. The company is headquartered in New York and trades on Nasdaq under the symbol DFTX.