Clinical Systems Manager (CSM)

Company: MAPS Public Benefit Corp
Location: Santa Cruz
Posted on: July 25, 2020

Job Description:

Join our team: change the world while working from home 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 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. 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 Director of Data Management & Services, the Clinical Systems Manager (CSM) will lead the Clinical Systems Team and the evaluation, selection, and implementation of clinical systems supporting the administration of clinical trials by Clinical Operations. The CSM will work closely with the Clinical Data Manager to ensure standardization in the process for collection of metrics and data. They will also ensure the information is provided to the business in a format that can enable informed decision making. The CSM is expected to support the technical oversight of all clinical systems which may include setting up and monitoring interface with external vendor systems and working with IT contractors on user enhancements and updates. 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 to the Santa Cruz or Oakland offices in California may be required. 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. Minimum Requirements Bachelor’s Degree in a scientific field 5 years’ direct experience working with clinical software solutions in clinical operations, eTMF operations, CTMS, and/or trial management. General knowledge of and experience working in a GCP environment Demonstrated communication and technical writing skills Strong computer and analytical thinking skills Goal-oriented, self-starter with proven ability to work independently Position Duties Applying systems analysis techniques and procedures, including consulting with users, to determine hardware, software, or system functional specifications for CTMS/eTMF Design, development, documentation, analysis, creation, testing or modification of CTMS/eTMF systems, based on and related to user or system design specifications Administration of reporting systems and preparation of metric reports Work with clinical operations study teams to ensure the accuracy of data in clinical systems Provide support to regulatory system (CTMS, eTMF) end users, including receipt, evaluation and recommendation for all issue/enhancement requests. Hands-on training support as required. Collaborate with the technical team as needed to support system enhancement and roll out of changes/enhancements. Support the development of training material/user manuals/learning solutions and end user training for clinical systems. When applicable, oversees implementation, validation, user acceptance testing (UAT), configuration, systems integration, and generation and maintenance of auditable documentation. Works with vendors and programmers on systems upgrades, licenses, and maintenance, and communicates to wider MPBC team, as necessary. CTMS/eTMF project management CTMS configuration Supporting development of Systems Standard operating procedures/work instructions Training MPBC staff on clinical systems Management of a team supporting Quality Management Systems with focus on regulatory compliance and Inspection readiness Additional Competencies Familiarity with Title 21 CFR Part 11-compliant systems as a superuser or application manager Very strong proficiency with a range of software applications (SharePoint, Microsoft Office etc.) and ability to quickly learn new ones Sound technical understanding of different operating systems and ability to troubleshoot issues for end users Patience and attention to detail with the ability to train end users of differing experience and technical understanding Ability to work independently and within a team Open and clear communicator Excellent written and verbal communication skills Confident and influential approach Self-motivating, able to prioritize and take initiative Make informed decisions based on guidance from manager and take responsibility for actions Possess sound judgment, discretion and be detail orientated Able to understand the needs of others Strong organizational skills with attention to details and timelines Able to work quickly in a remote virtual setting 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 Experience with health authority audit support, Pharmacovigilance systems, Regulatory system & database troubleshooting, Enterprise Resource Planning FLSA Status : Exempt Compensation : Salary depends on experience. Includes excellent benefits package.

Keywords: MAPS Public Benefit Corp, Santa Cruz , Clinical Systems Manager (CSM), Other , Santa Cruz, California