IMP Supply Manager (ISM) – Logistics

Home » Our Mission » Careers » IMP Supply Manager (ISM) – Logistics

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. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. 

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, 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.

Call for Candidates

Reporting to the Director of CMC and Project Management, the IMP Supply Manager (ISM) manages the IMP supply logistics (domestic and international), including related timelines, investigative site and depot IMP release, temperature and technical/quality complaints, and inventory from all vendors for all new and ongoing clinical trials being managed by MPBC and MAPS Europe B.V.

The ISM sets-up (as needed and appropriate), manages, and oversees associated systems such as IWRS, CTMS, and Smartsheet. All activities are managed in-line with program-wide timelines, in accordance with relevant Standard Operating Procedures (SOPs), and the principles of appropriate GxPs, specifically GCP.

The ISM must enjoy working in a small, entrepreneurial environment that is mission-driven, results-focused, and research-oriented.

Interested and qualified candidates are encouraged to apply online at: tinyurl.com/applyMPBC

 

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 for frequent phone and internet meetings. Preference will be given to applicants living on the East Coast.

 

Hours

Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday – Friday). The exact schedule may be arranged upon hire. Occasional night and weekend hours may be required with advance arrangement. Meetings with MAPS PBC in California (PST) are required from time to time.

 

Position Duties

  • Provide technical support for video processing tasks, both internally and externally.
  • Operate and troubleshoot proprietary hardware and software environments.
  • Develop and support web applications for internal and external use.
  • Develop automated data transfer systems and protocols.
  • Provide quality assurance.
  • Build video recording systems for Expanded Access, MP18, MAPP3, and other future studies.
  • Assigning Adherence Raters and Supervisors video review tasks.
  • Support therapists with video system setup and accessing recordings.
  • Support the release of videos to participants.
  • Support Senior Independent Raters in editing and distributing videos.
  • Support internal staff in recording and distributing online training videos and webinars.
  • Scale existing cloud infrastructure.
  • Reports to Video Systems Manager weekly and participates in regular meetings on the project, department, and organizational level.
  • Facilitate organizational documentation; including Standard Operating Procedures (SOP’s), spreadsheet tracking, and other related processes.
  • Manage project tasks on Asana and contribute to project management.
  • Perform occasional EU site visits.

Minimum Requirements

  • A bachelor’s degree preferably in science or related field
  • 3 years relevant experience in randomization systems with a strong interest in drug development and clinical research
  • Knowledge of applicable regulatory frameworks, such as CRF 21 and ICH GCP
  • Experience with project management concepts and activities (e.g. Gantt charts and project plans)
  • Demonstrated willingness to stay abreast of development in the area of professional competence

Additional Competencies

  • Ability to work independently and within a team, following the direction of the Director of CMC and Project Management
  • Open and clear communicator with excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivated, able to prioritize, take initiative, and work quickly in a remote, virtual setting
  • Possess sound judgment, discretion, and the capacity to understand the needs of others
  • Strong organizational skills with the ability to plan and coordinate tasks, while managing competing priorities and timelines
  • Ability to recognize potential obstacles, and deliver conscientious and precise work even when under pressure
  • Demonstrate a results-oriented approach, determination, responsibility, and accountability
  • Strong computer skills, facility with word-processing, spreadsheets, and project management applications

 

General Responsibilities

IMP Supply Management

  • IMP supply/re-supply logistics and destruction for all trials (5+ per year) managed by MPBC
  • Set-up and oversee all IMP inventory management and IWRS systems utilized or required by MPBC
  • Manage IMP supply, relabeling (including all investigative site or depot IMP relabeling activities), and destruction timelines using Smartsheet
  • Manage CTMS IMP trial-specific modules, including data entry and reconciliation, as needed
  • Forecast investigative site/depot level IMP supply/re-supply needs in collaboration with Study Manager(s)
  • Act as single MPBC unblinded IMP Supply Manager, managing inventory across multiple vendors, investigative sites, and depots, including blinded inventory
  • Track all program and trial-level IMP import/export permits and associated documents
  • Manage the initial release of IMP at investigative sites/depots and subsequent release following allowed temperature deviations, etc.
  • Send IMP shipments to domestic/international investigative sites/depots and third-party investigators according to current processes and associated SOPs/WIs

Documentation

  • Support creation, review, and update of relevant SOPs
  • Oversee filling of all trial-related IMP and randomization essential documents within the respective eTMFs
  • Support the creation of study-specific IMP related plans, logs, and processes according to established SOPs and templates
  • Assist in the creation of IMP-related study training materials

Meetings and Other Responsibilities

  • Attend relevant vendor project management calls
  • Participate in CMC and Project Management team meetings
  • Maintain effective communication with other members of the CMC and Project Management and Clinical Operations teams
  • Other responsibilities as assigned

FLSA Status

Non-Exempt (i.e. eligible for overtime)

Compensation

Salary range disclosed upon request. Includes full benefits package.

MAPS Public Benefit Corporation

Our Mission
Who We Are
Careers
News
FAQ
Contact Us

1115 Mission Street
Santa Cruz, CA 95060-9989

MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.