Remote Clinical Trial Manager

Summary

Join MindMed, a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. We are seeking an Early Phase Trial Lead to lead and manage clinical trials, oversee CRO/Vendor partners, and maintain therapeutic knowledge.

Requirements

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 4 years clinical trial experience in the pharmaceutical industry or CRO
• Experience with managing Early Phase 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
• 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
• Experience in vendor management strongly preferred
• Must possess excellent leadership skills and proven ability to foster team

Responsibilities

• Serve as early phase trial lead and primary (internal and external) contact for assigned clinical trial(s)
• Lead and/or manage (if outsourced) clinical trial(s) to ensure they are conducted in accordance with approved scope of work/budget, US/ex-US regulatory guidelines and operate within established timelines with oversight by the Director of Clinical Operations
• Manages outsourced clinical operations functions, which may include Clinical Research Organizations (CRO), data management, vendors, etc
• 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
• Oversee monitoring activities by reviewing visit reports and protocol deviations Oversight of CRO monitoring team activities and deliverables
• Attend site visits as a co-monitor and quality check, as necessary May be assigned a trial site to monitor as necessary
• 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
• If assigned as operational lead for early phase trial(s), perform financial management, including review and approval of site contracts and budgets, as well as CRO/Vendor invoices and accruals with oversight by the 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 and processes
• 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

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave