Clinical Systems Specialist - Remote Position

Data Management and Services · Any City, Any State, California
Department Data Management and Services
Employment Type Full-Time
Minimum Experience Mid-level

About MAPS Public Benefit Corporation (MAPS PBC)

MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) nonprofit that is at the forefront of the rapidly growing psychedelic medicine industry and movement and is a leading advocate for drug policy reform. 

 

MAPS PBC’s current focus is developing MDMA-assisted therapy as a breakthrough treatment for PTSD with plans to submit for FDA approval in 2022. In May 2021, the results of our successful Phase 3 clinical trial were published in Nature Medicine and profiled on the front page of The New York Times

 

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. 

 

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

MAPS PBC is a dispersed workforce that offers full-time employment in a dynamic remote work environment. This means our employees enjoy competitive salaries and benefits packages, as well as the comfort of working from their own homes. Through the conscious use of technology, we stay connected to our team members and professional community while, at the same time, enjoying the freedom of a remote environment.

 

We are committed to conscious leadership and an inclusive team dynamic. Our culture is one of mutual respect, responsibility, and trust. Our employees’ health and happiness are priorities, and we treat our staff like people, not numbers on a spreadsheet.

 

MAPS PBC is at the forefront of changing the way mental health issues are treated and is committed to bringing dignity and access to overcoming mental health challenges through the conscious use of psychedelics. We believe we are changing the world, and we want you to be a part of it.

 

Position Summary

Reporting to the Clinical Systems Manager, the Clinical Systems Specialist (CSS) provides support to MPBC study teams conducting clinical trials in accordance with applicable regulations and MPBC SOPs. The CSS should possess familiarity in working with electronic Trial Master File (eTMF), preferably in a clinical trial setting, experience with Clinical Trial Management Systems (CTMS) configuration and reports is desirable. The CSS will coordinate system/application design, configuration, implementation, testing, user access, system issue management, and supporting the processes to maintain, develop, and test clinical systems/applications infrastructure and services supporting clinical trials. The individual must have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational skills, and the ability to maintain a realistic balance among multiple priorities. The CSS must be creative and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven and research-oriented.

 

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Occasional travel may be required.

 

Hours

Full-time. We are a West Coast-based company and applicants must be available during normal business hours (9:00AM - 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.

 

Minimum Requirements

  • Experience with quantitative research methodology and a Bachelor’s degree with a major in a quantitative or scientific field is required
  • At least two years of relevant experience working with cloud-based systems/applications is preferred
  • The ideal candidate will possess technical proficiency, understanding a variety of programming and coding languages, and working with reporting/query tools
  • The candidate should be willing to stay abreast of the development in the area of professional competence, the ability to understand requirements in whole and in detail and the ability to utilize technical problem-solving skills to investigate, debug, and effectively report issues
  • Demonstrated customer responsiveness in all end-user interactions

 

Position Responsibilities

  • Primary responsibility: ensure User Access and deactivation logs are audit ready, provide applicable system access training and permissions for eTMF, Quality Connect Systems and CTMS
  • Work with end users of eTMF and CTMS to ensure harmonization of File Plan and system standards on a regular basis
  • Ensure that relevant system SOPs are adhered to for applicable systems (e.g. regular quality checks and reviews)
  • Provide leadership for the systems for which the CSS is accountable
  • Coordinate UAT activities of clinical systems, including but not limited to EDC, CTMS, eTMF to complete in-house validation activities per Title 21 CFR Part 11, as applicable
  • Conduct configuration of clinical systems per approved plans
  • Support tracking, analytical investigations, and resolution of clinical system issues
  • Support tracking and filing of essential regulatory documentation
  • Support system enhancement and roll out of changes/enhancements
  • Provide hands-on training support as required
  • Support development of training material/user manuals/learning solutions and end user training for clinical systems
  • Provide end user training, generation and maintenance of auditable documentation
  • Support generation and maintenance of auditable clinical system documentation
  • Work with vendors and programmers on systems upgrades, licenses, and maintenance, and communicate to wider MPBC team as necessary

 

Additional Competencies

  • Self-motivated with the ability to work independently and within a team
  • Open and clear communicator
  • Excellent written and verbal communication skills, especially in communicating business technical information and statistical information and specifications
  • Capable of preparing and delivering requirements and test plan documents
  • Strong interpersonal skills that can be used to effectively collaborate on work with other professionals
  • Ability to present to small groups
  • Demonstrates a results-orientation, determination, ownership of responsibility, reliability, and accountability, while functioning as a team member and following direction as part of a team under general supervision
  • Experience working with clinical trial documents and data
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure

 

FLSA Status

Non-Exempt (this position is eligible for overtime)

 

Compensation

Hourly rate based on experience; 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!

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  • Location
    Any City, Any State, California
  • Department
    Data Management and Services
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level