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Clinical Project Manager (Associate Director)

ATAI Life Sciences

ATAI Life Sciences

Operations
United States · Remote
Posted on Wednesday, April 17, 2024

Who we are: Atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health conditions so that everyone, everywhere, can live a more fulfilled life. We aim to enable mental health patients to achieve clinically meaningful and sustained behavioral change by developing rapid-acting compounds with durable efficacy as well as digital therapeutics. We operate a hybrid virtual/in-person working model, with most of the team spending time in our offices as required. Atai hubs are in Berlin and New York City.

What we offer:

  • Compensation package inclusive of yearly bonus and generous stock options
  • Annual company offsite in U.S or Europe
  • Hybrid work model and home office budget
  • Mental health wellness program, including 10 company-paid therapy sessions a year
  • Sports Club membership (Class Pass, Urban Sports)
  • 100% paid medical insurance for U.S, and 50% employer contribution for DE
  • 401(k) program for U.S and 100% employer matched pension scheme for DE & UK

What is the role (purpose)

  • To set-up; execute and close-out early phase clinical trials according to ICH/GCP guidelines and regional regulations

What you will achieve:

  • Work closely with the CRO staff to provide information to the project team on-site activation metrics including, but not limited to, the status of the following: site information, regulatory and ethics approval, controlled substance approval (where applicable), SIV date, contract, budget, letter of indemnity (LOI), confidentiality agreements (CDAs), and ancillary site committee approvals.
  • Verify that site-specific essential regulatory documents are complete and correct. Complete/oversee the completion of IMP greenlight forms and site activation sign-off as needed.
  • Ensure successful design, implementation and tracking of clinical trials.
  • Establish and lead core project teams and facilitate their ability to complete trials within timelines.
  • Ensure the critical internal stakeholders e.g., Biometrics, Regulatory, Pre-Clinical, Psychotherapeutic development, Clinical Development, Clinical Sciences are fully informed of study requirements and are able to contribute as required to the trial program.
  • Propose and manage financial budgets and timelines for clinical trials.
  • Be responsible for the writing and review of the trial protocol, CRF, and other essential trial documentation.
  • Assist with the writing and review of data management, statistical analytical and clinical study reports.
  • Define and manage project resource needs and establish contingency plans for key resources.
  • Participate in the evaluation and selection of Clinical Research Organizations (CROs) and required external vendors
  • Co-ordinate the establishment of service provider contracts.
  • Liaison and oversight with CROs and other external vendors to facilitate their ability to complete trials within timelines and to the required quality
  • Ensuring appropriate training is provided for the internal teams to conduct the trials.
  • Ensuring clinical trials are run in accordance with SOP’s and relevant regulatory guidelines.
  • Develop productive working relationships with internal colleagues, investigational site staff and CRO/vendor personnel to ensure high quality reporting throughout all study teams.
  • Maintenance of good working relationships with key opinion leaders.
  • Organize and participate in Investigator Meetings, presenting trial data and training clinical staff.
  • Visit global investigational sites to assist with site training and understanding of project requirements.
  • Attend relevant International Symposia and keep up to date with significant new research findings appropriate to the therapy area.
  • Participate in the development and review of SOPs pertaining to clinical activities.
  • Provide regular status reports to Senior Management and Project Team.
  • Carry out work in a way that will not adversely affect their own, or others, health, safety, and security or the environment and reports any shortcomings in atai arrangements.

Who will be successful in this role:

  • Broad Clinical Trial experience gained over 5+ years
  • Knowledge of relevant SOPs, ICH/GCP, and regulatory guidelines
  • Preferably with CRA, CPA, or Start-up Lead experience