Clinical Trial Manager

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.   

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.

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
  
  

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

The starting base pay range for this position is $110,000.00 - $145,033.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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 and some fun fringe perks!