Senior Clinical Trial Manager

Job not on LinkedIn

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $160k - $190k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 2%

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• Provide site- and/or country-level clinical trial management and vendor/external service provider oversight • Serve as Clinical Operational Trial Lead when assigned, overseeing cross-functional delivery from protocol synopsis through Clinical Study Report and trial-results disclosure • Ensure high-quality deliverables within timelines, budget, SOPs, GCP/ICH guidelines, and applicable FDA and state regulations • Review monitoring visit reports, schedules, metrics, protocol deviations, issues, and action items using Definium or CRO systems • Serve as sponsor contact for vendors and oversee deliverables, patient enrollment, data collection, risks, timelines, and budgets • Maintain therapeutic knowledge and familiarity with clinical protocols and projects • Revise vendor scopes of service, budgets, plans, and timelines with CROs/vendors • Oversee CRO monitoring team activities and deliverables • Assist Quality Assurance with site audits • Review and contribute to protocols, eCRF designs, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study documents • Manage site contracts, budgets, vendor invoices, and accruals • Track and coordinate investigational product, clinical trial materials, and laboratory samples • Organize site round-table and recruitment meetings • Participate in departmental SOP, systems, and process development • Ensure external service provider selection and setup align with protocol requirements, budgets, and timelines • Maintain inspection readiness, data integrity, and overall data quality • Ensure trial-specific training for trial team members and CRO personnel

🎯 Requirements

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) • 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, ideally in the psychiatric space • Willingness and ability to travel up to 20% of the time, defined by business needs • Strong organizational skills and attention to detail • Ability to work effectively in a fast-paced and dynamic environment • Clinical research operational knowledge • Project planning and management skills • Communication and presentation skills • Ability to manage all aspects of clinical trial execution • Experience managing teams in a virtual environment • Experience in vendor management strongly preferred • Excellent leadership skills and proven ability to foster team productivity and cohesiveness

🏖️ Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave • Fun fringe perks • Additional compensation, including bonus and equity, may be available