Full Time
Remote
Posted 1 month ago

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD.  MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine or profiled on the front page of The New York Times.  

MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.  

Why work for MAPS Public Benefit Corporation (MAPS PBC)? 

  • We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.
  • We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work.
  • We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency.

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment. 

Clinical Data Manager Executive Summary

Reporting to the Director of Data Management & Services as a part of the Data Management Team, the Clinical Data Manager (CDM) will provide data management deliverables to facilitate the execution of Phase I-III clinical trials. The SCDM will support data management activities covering study start-up, progression, and close-out within the Electronic Data Capture (EDC) system for projects conducted by MAPS PBC. The SCDM will utilize knowledge of ICH-GCP standards, Title 21 CFR Part 11, and clinical research industry best practices, as well as proficiency in all aspects of data management, from study start-up to study close-out/archiving.

Key Responsibilities

  • Responsible for Study Level Documentation: The Clinical Data manager will Develop and review key documents such as data collection instruments, database design specifications, edit check specifications, data transfer specifications, Data Management Plans, annotated eCRFs for biostatistician using available templates.
  • Lead Study Level User Acceptance Testing and Validation: The Clinical Data manager will develop and review User Acceptance Testing (UAT) plans, role-based test scripts, execution logs, and participate in UAT as dictated by role. They will be key in ensuring that all study level databases are built to the highest quality and data integrity standards.
  • Build Study Database in EDC system: The Clinical Data manager will be responsible for the creation of the study level database in the EDC system and creation of data validations and listing.

Minimum Requirements

What you bring to the role:

  • A Bachelor’s degree in a scientific or quantitative field
  • Minimum of 3 years of relevant experience in a research work environment
  • Proficiency in all aspects of data management and database design concepts
  • Working knowledge of ICH-GCP and FDA regulations
  • Assumes responsibility and accountability for results
  • Experience in eDC design and build preferred

MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.  

Competitive benefit package includes:

  • Paid Time Off (PTO)
  • Sick Time
  • Holiday Pay
  • Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
  • Employer funded mental health HRA
  • Employer funded SEP IRA
  • FSA/Dep Care
  • Pet Insurance
  • Home Office Stipend
  • Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!

Job Features

Job Category

Clinical

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