Definium Therapeutics · 1 hour ago
Senior, Clinical Trial Manager
Durham, NC
Full-time
Onsite
Senior Level
$169K/yr - $193K/yr
6+ years expDefinium Therapeutics is a clinical stage biopharmaceutical company focused on developing treatments for brain health disorders. The Senior Clinical Trial Manager will oversee clinical trials, manage external service providers, and ensure compliance with regulatory requirements while leading cross-functional teams to deliver high-quality results.
Biotechnology
Responsibilities
Lead the management and oversight of contract Clinical Research Associates; utilize MindMed or CRO systems (when outsourced) to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality
Serve as Sponsor contact for external service providers/vendors with overall responsibility ensuring deliverables are executed with high quality and within timelines and budget
Oversees and tracks CRO/Vendor partners to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed
Maintain therapeutic knowledge and familiarity with clinical protocol(s) and project(s) as appropriate
Work with CRO/Vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Oversight of CRO monitoring team activities and deliverables
Assist QA with site audits
Review and contribute to study protocols, changes in eCRF design, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study-related documents/plans
Perform financial management, including review and approval of site contracts and budgets, as well as CRO/Vendor invoices and accruals with oversight by the Senior Director of Clinical Operations
Assist in tracking and coordination of trial related materials, including investigational product, clinical trial and laboratory samples, etc
Organize and manage site round-table meetings and site recruitment meetings
Participate in the development, review and implementation of departmental SOPs, systems (CTMS and eTMF) and processes
Provide oversight and act in an SME capacity for Medidata CTMS
Provides oversight of external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines
Ensures that the trial team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools
Ensures trial team members have received the appropriate trial-specific training needed for their function; in collaboration with the study clinician, ensures appropriate trial-specific training is given to trial team members and/or to the CRO
Qualification
Required
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; ideally in the psychiatric space
Strong analytical and critical thinking skills to support decision making with the onboarding of systems (CTMS, eTMF, EDC); Medidata platform experience preferred
Willingness and ability to travel up to 20% of the time, defined by business needs
This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment
Requires clinical research operational knowledge, project planning/management, communication, and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing teams in a virtual environment is required
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
Preferred
Prior experience as a CRA strongly preferred
Strong analytical and critical thinking skills to support decision making with the onboarding of systems (CTMS, eTMF, EDC); Medidata platform experience preferred
Experience in vendor management strongly preferred
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 and some fun fringe perks!
Company
Definium Therapeutics
Definium Therapeutics (formerly MindMed) is a biotech company forging a new era of psychiatry by applying precision to psychedelic medicine.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase