Job description
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, or Director/Senior Director of Clinical Operations.
Responsibilities:
Accountability as the SME for the CTMS system in house
Submission/Document Tracking into CTMS
Access Management
Adding/updating study, country and site level milestone dates into CTMS
Adding team members (internal + external)
Accountability as the SME for the eTMF system in house
Access Management
Taking the eTMF Plan template and inserting study specific details (protocol, protocol #) and providing to CTM for review/updates
Meeting with each department to talk through and update the eTMF index based on study needs
Creating a package of placeholders based on the eTMF Index
Sponsor QC of all documents uploaded by CRO
Review and approval of all documents submitted by the CRO/vendors to the eTMF
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
Accountable for oversight and tasks associated with maintaining inspection readiness
Providing 1572s to Regulatory for submission
Management and oversight of Internal Training
Vendor Oversight and quarterly reviews and tracking
Maintain Study Org Chart + Study Tracker for assigned clinical trials
Work with team to decide Clin Ops SharePoint filing structure and then update our files to this structure
Ensuring storyboards align between early and late phase
Sets up and attends internal meetings, takes meeting notes, and updates and distributes meeting minutes
Organizes and helps plan external meetings. May interact with meeting planners and travel agents
Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance
Provides general administrative support to the clinical team as assigned
Performs other duties as assigned
Requirements:
At least 2 years of clinical trial experience in 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
Experience managing and working in CTMS and eTMF systems
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 $53,032.00 - $98,800.00. 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!
