Clinical Project Manager (Remote)

atai Life Sciences is a biopharmaceutical company focused on developing novel treatments (both psychedelic and non-psychedelic) for mental health disorders, enabling everyone to live a more fulfilled life. Our work involves the development of innovative compounds and digital therapeutic tools. We are committed to advancing the treatment landscape and have a strong emphasis on collaboration, innovation, and responsibility. Our offices are located in Berlin and New York.

Role Purpose

The Sr. Clinical Project Manager (Sr. CTM) will oversee the planning, execution, and close-out of clinical trials, ensuring they are conducted in compliance with ICH/GCP guidelines and regional regulations. This role is central to driving the success of clinical trials by coordinating with internal teams, CROs, and external vendors, managing timelines and budgets, and ensuring high-quality outcomes throughout the trial lifecycle. Additionally, the role includes supporting essential project tasks that contribute to the overall efficiency and smooth operation of clinical trials.

What You Will Achieve

Clinical Trial Management:

• Oversee and manage the end-to-end clinical trial process, including protocol design review, study start-up, implementation, and close-out.
• Collaborate with CROs and ensure operational metrics are on track, including site information, regulatory approvals, contract management, and essential documentation.
• Ensure the successful completion of site-specific regulatory documents, IMP greenlight forms, and site activation sign-offs.
• Facilitate the establishment and leadership of core project teams to ensure trials are completed within timelines and budgets.
• Maintain clear communication with internal stakeholders (CMC, Regulatory, Clinical Development, etc.) to align study requirements.
• Propose and manage financial budgets and timelines for clinical trials.
• Lead the oversight and review of trial documents including, CRFs, operational plans and other regulatory essential documentation.

Project Coordination

• Assist in the development, review, and internal alignment of study-related documents, ensuring they meet the project’s needs.
• Support the preparation and submission of IRB/IEC applications, including managing the approval process and coordinating responses to inquiries.
• Ensure legal and regulatory compliance by coordinating the review and approval of contracts and submission documents.
• Maintain oversight of the Trial Master File (TMF) and ensure effective document management across the project.
• Facilitate communication and coordination with CROs and sites to ensure smooth trial operations, including managing study supplies and monitoring data quality.
• Participate in database lock activities, supporting query resolution, data review, and ensuring data integrity.

Vendor And Stakeholder Management

• Participate in the evaluation and selection of CROs and external vendors, ensuring they meet trial quality and timeline requirements.
• Oversee service provider contracts and maintain productive working relationships with key opinion leaders and investigational site staff.
• Organize and participate in Investigator Meetings, presenting trial data and training clinical staff.
• Visit global investigational sites for training and project support as needed.
• Manage third-party vendors and CROs to ensure effective project delivery.

Regulatory Compliance And Reporting

• Ensure all trial activities comply with ICH-GCP guidelines, regional regulations, and atai SOPs.
• Provide regular status reports to Senior Management and Project Teams, ensuring transparency and proactive issue resolution.
• Participate in the development and review of SOPs related to clinical activities.

Who Will Be Successful In This Role

• Experience:
• Broad clinical trial experience with 5+ years in a related role, including exposure to trial management.
• In-depth knowledge of relevant SOPs, ICH/GCP, and regulatory guidelines.
• Proven ability to manage both clinical and administrative tasks effectively.
• Key Skills and Attributes:
• Attention to Detail: Vigilant in ensuring that all details are handled meticulously, preventing errors that could impact project timelines or quality.
• Effective Communication: Capable of clear, persuasive, and succinct communication, both verbally and in writing, ensuring all stakeholders are aligned.
• Prioritization/Planning: Skilled at organizing, scheduling, and budgeting efficiently to keep the team focused on key priorities.
• Proactivity: Demonstrates initiative by acting independently and bringing innovative ideas to the table without needing direct prompts.

Those who succeed at atai align with our values of Rooted in Purpose, Seeing Opportunity Where Others See None, Keep it Simple and Work the Problem, and bring these principles to every aspect of their work.