Access and Strategy Intern

Remote

Reporting to the Chief of Staff, the Access and Strategy Intern will support key organizational initiatives, including implementation of MAPS PBC’s new Health Equity initiative within the Expanded Access program. The Access and Strategy Intern will work closely with clinical sites to develop / refine budgets and coordinate grant administration to improve equitable access to MDMA-assisted therapy. The Access and Strategy Intern may also support and/or lead other initiatives within the domains of pre-commercial planning, provider training, and organizational development.

Director/Associate Director of Clinical Operations

(Based on experience) – Remote

Associate Director (AD) provides operational leadership, management and guidance for success across Clinical Operations.

Associate Director of Quality Assurance

Remote

MAPS PBC is seeking a GCP quality assurance professional to support the maintenance and continuous process improvement of the GxP Quality System.

Clinical Development Project Manager

Remote

The Project Manager will lead a newly-created project management function that supports MAPS PBC in preparing for launching its first product: MDMA-assisted therapy for the treatment of PTSD. They will provide strategic leadership, operational management, and oversight of cross-functional projects that span Clinical Development, Regulatory Affairs, CMC, Commercial, Training & Supervision, and Finance. The Project Manager will be responsible for planning projects and ensuring they are implemented on time, on budget, and to a high-quality standard. The initial focus will be on preparation for rolling NDA submission in 2021-2022.

Clinical Research Associate

Remote Contracting Position

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The CRA role will report to the Director of Clinical Operations or the Clinical Program Operations Manager and will ensure that clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually.

Clinical Systems Specialist

Remote

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.

Clinical Trial Leader

Remote

The CTL is responsible for managing, implementing and maintaining oversite of clinical studies in a team setting over multiple protocols. CTL responsibilities include: managing assigned clinical study protocols from conception through database lock and clinical study reporting, mentoring CRAs/CSAs; contributing to protocol development, including amendments, task management of assigned clinical trial sites, CRAs/CSAs, communicating clinical program timelines, coordinating clinical supplies and budgets.

Executive Assistant

Remote

Reporting directly to the CSO and COO, the Executive Assistant provides executive support, calendar management, coordinates executive outreach and internal relations efforts; coordinate communications and agreements with external stakeholders, and oversees special projects as needed. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, administrative, and organizational skills, and the ability to maintain a realistic balance among multiple priorities.

Regulatory Medical Writer

Remote

MAPS PBC is seeking an enthusiastic, organized, and flexible team player to join the Regulatory Affairs Department as a Regulatory Medical Writer (RMW). Reporting to the Regulatory Affairs Manager, the RMW will be responsible for supporting regulatory document writing to develop the global evidence base for MAPS-sponsored research.

Regulatory Publishing Specialist

Remote

Reporting to the Regulatory Affairs Manager, the Regulatory Publishing Specialist supports functions related to tracking regulatory information and document styling and publishing in eCTD format for regulatory submissions. The individual in this position supports global regulatory programs, projects, and compliance initiatives across regions and business units.  

Safety Associate

Massachusetts

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The Safety Associate role will report to the Chief Medical Officer and will ensure that clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. Suitable candidates can work well in a fast-paced environment and adept at organizing and managing large volumes of information virtually.

Study Coordinator

Charleston, South Carolina

The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Clinical Investigator and the Sponsor.

Study Coordinator

Fort Collins, Colorado

The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Clinical Investigator and the Sponsor.

Study Coordinator

Los Angeles, California

The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Clinical Investigator and the Sponsor.

TMF Associate

Santa Cruz, California

Reporting to the Systems Manager on the GxP eSystems Team in the Department of Data Management & Services, the Trial Master File (TMF) Associate is primarily responsible for filing of auditable regulatory document filing on paper TMF and in the Montrium eTMF for clinical trials. This position also supports TMF clean-up efforts and inspection readiness of Essential Documents to support clinical trials.

About MAPS PBC

Independent Rater
Portugal and Germany

MAPS Europe B.V., a trial sponsor, aims to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD).

Clinical Trial Leader
Remote

MAPS Europe is seeking an enthusiastic, focused, and organized Clinical Trial Leader.

Clinical Research Associate – The Netherlands
Remote

MAPS European team is seeking an enthusiastic, focused, and organized Clinical Research Associate to join our Clinical Operations Department.