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.
The Clinical Trial Assistant, Clinical Operations, has primary accountability at the trial level within the organization. The Clinical Trial Assistant will be accountable to help administratively manage, plan and scale clinical operations in support of the execution of our clinical research studies in the field of psychiatry, neuroscience, and/or addiction medicine (from the protocol concept through the clinical study report, ensuring completion of study deliverables). The Clinical Trial Assistant supports the efforts of Clinical Operations and performs a variety of administrative assignments under the guidance and direction of the Senior Clinical Trial Associate, Associate Director, Director and Senior Director of Clinical Operations.
RESPONSIBILITIES:
- Establishes, performs quality control, maintains, and archives the Trial Master File (i.e., electronic folder set-up, filing, tracking, archiving) in compliance with DIA Reference Model, SOPs, ICH and GCPs. Ensures proper naming conventions are followed
- Performs TMF quality reviews for both in-house and CRO-led trials
- Coordinates distribution of documents and equipment/materials to sites as well as monitors, central/core laboratories and CROs
- Collects, tracks and reviews regulatory documents and notifies sites, monitors or CRO of missing or expired documents
- Develops and maintains spreadsheets and other documents to track critical study milestones
- Tracks and reports on project or study information regarding subject and site status, metrics, lab sample shipments and discrepancies, and other parameters as appropriate
- Prepares or assists with the preparation and review of study-related materials as it pertains to CTA processes (e.g., study reference manual, clinical trial material requests, and Investigator Site File)
- Participates in team review of data listings and clinical study reports. Submits required documentation for appendices of clinical study reports or for inclusion into a regulatory filing
- Organizes study information on the shared file drives and retrieves information from the central/core laboratories or CRO portals
- Assists Clinical with oversight of third-party vendors and other clinical operations tasks.
- Performs assigned administrative activities in support of clinical trials from design to completion
- Participates in the planning and conduct of central/core laboratory, CRO and study-related meetings; creates agendas and draft minutes as appropriate
- Sets up and attends meetings, takes meeting notes, and updates and distributes meeting minutes
- Organizes and helps plan meetings. May interact with meeting planners and travel agents
- Communicates to internal and external team members (e.g., vendors, site personnel, and consultants)
- Coordinates the distribution of communications to all sites (e.g., questionnaires, newsletters, mass mailings, IND safety reports, Investigator’s Brochures, etc.)
- Assists the Clinical Operations Lead with tracking of vendor or site invoices and ensures accurate accrual records are kept with guidance from the Senior Clinical Trial Associate as needed
- Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance
- Provides general administrative support to the clinical team as assigned
- Processes forms, requests for information by the team, and requests to obtain information from vendors and investigative sites
- Performs other duties as assigned
- Responsible for managing general department administrative tasks as needed (up to 20%)
REQUIREMENTS:
- At least 2 years of clinical trial administration experience in a Pharmaceutical or Biotech company
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field
- Experience in Psychiatry and addiction medicine preferred
- Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA
- Past experience in development of tools and other tracking documents that support clinical research
- Strong working knowledge of MS Project and developing Gantt charts
- Advance knowledge of MS Excel
- Excellent oral, written, and communication skills required
- Problem-solving and strategic planning skills
- Excited by innovative ideas in clinical research space
- Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment
- Engaging, empathetic and dynamic personality; ability to understand the problems of others and delight in finding solutions
The starting base pay range for this position is $58,000.00 - $74,880.00. 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!