MAPS PBC is seeking a motivated, enthusiastic Clinical Data Manager (CDM) to support the Data Management Team in the execution of Phase I-III clinical trials. Reporting to the Director of Data Management & Services, the CDM 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 CDM will utilize knowledge of ICH-GCP standards, Title 21 CFR Part 11, and clinical trial processes, as well as proficiency in all aspects of data management from study start-up to study close-out. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, and organizational skills, and the ability to maintain a realistic balance among multiple priorities.
Location: Santa Cruz, California, United States (Remote)
Job Type: Full-time, Contractor
Hours: Full-time, 40 hours per week. We are a West Coast-based company and applicants must be available during normal business hours
(9:00 AM – 6:00 PM Pacific Time, Monday through Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
More information about the organization is available at https://mapspublicbenefit.com.
MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.
We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, 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. MAPS PBC strives to continually improve upon the supportive, equitable, and accessible work environment.
What You’ll Be Doing
- Contribute to development of clinical trial database specifications, including electronic Case Report Form (eCRF) design, roles and permissions, query logic, edit check specifications, and data transfer specifications,
- Generate Data Management Plans, annotated eCRFs for biostatistician, source mappings, and eCRF instructions for end users using available templates
- Develop role-based test scripts and execution logs for User Acceptance Testing (UAT) of EDC systems
- Conduct and document EDC issue analysis, investigation, and clean-up
- Generate data listings to facilitate central reviews needed for data clean-up, database reconciliation, data review, and discrepancy management
- Generate EDC screenshots for regulatory submissions, study measure license agreements, and issue reporting
- Review clinical research study protocols for database update implications
- Perform closeout activities including database freezes and locks to ensure archiving per applicable
- Develop EDC training materials
- File and track user training documentation and data management deliverables in electronic Trial Master File (eTMF)
- Maintain trackers for Issue Reporting, User Access Management, and User Roles and Permissions of EDC
- Assist with process development such as SOPs, work instructions, forms and templates for data management activities
- Record minutes during CDM meetings
- Report progress to appropriate project management, Clinical Operations, and Safety
- Communicate to internal and external clients (esp. regarding Data Management-led initiatives and issue reporting)
- Check in regularly with supervisor and complete assignments by agreed deadline
- Proactively seek methods of improvement, streamlining workflows, and building efficiencies in individual work and project outcomes
- Perform other duties as assigned by management
What We Expect from You
- A Bachelor’s degree in a scientific or quantitative field
- 2+ years of experience in clinical data management
- Proficient in data management and database design concepts
- Working knowledge of ICH-GCP and FDA regulations
- Excellent organizational skills with great attention to detail
- Ability to work independently and collaboratively within a team
- Open and clear communicator
- Excellent written and verbal communication skills
- Ability to work proactively and effectively in a fast paced, high change environment
- Demonstrated initiative and resourcefulness
- Assumes responsibility and accountability for results
- Proficient computer skills including MS office products
- The qualified applicant must be flexible, well-organized, and can work well under pressure as well as prioritize