Clinical Trial Leader

Call for Candidates

MAPS European team is seeking an enthusiastic, focused, and organized Clinical Trial Leader to join our team.

Position Summary

To 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. The CTL is responsible for managing, implementing and maintaining oversight of clinical studies in a team setting over multiple protocols. Core CTL responsibilities include:

• Manage assigned clinical study protocols from conception through database lock and clinical study reporting.
• Coordinate regulatory and ethics committee submissions, including authoring of relevant documents.
• Close collaboration and oversight of CRA/CSA deliverables.
• Author and revise relevant study documents.
• Oversight of all site-level activities. serving as critical interface between sites and sponsor.
• Coordinate clinical trial supplies, IMP, and budget.

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.

Hours

Full-time, 40 hours per week. Responsibilities will be mainly carried out during European time-zone working hours, however some flexibility will be required to meet with other MAPS representatives based in the Pacific time-zone (USA). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

Minimum Requirements

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor’s degree preferred. A minimum 5 years global (multi-country) study management or equivalent experience, ideally within Europe.
Knowledge of medical practice/techniques and terminology. Expert knowledge of clinical research study design and process. Knowledge of U.S. and European regulations governing clinical trials, demonstrated ability to adhere to GCP and regulatory standards. Demonstrated experience preparing, gaining approval and managing clinical protocols.

Additional Competencies

• Ability to work independently, lead a team and work well 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 lead, motivate and understand the needs of others
• Strong organizational skills with attention to details and timelines
• Able to work quickly in a remote virtual setting
• Computer skills, facility with word-processing and spreadsheet applications
• 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
• Ability to make public presentations and represent MAPS at conferences

Responsibilities

General Responsibilities

• Preparation and finalisation of protocol, amendments, and protocol related documents. Coordinate input form the Medical Monitor and team reviewers, taking an active part in study design, internal discussion and site discussion
• Coordinate creation of and review of ICF, CRFs, Source Records, Study Reference Manual, Quality Plans, Risk Assessment (RACT) etc. working cross functionally amongst teams to maintain consistency
• Coordinate IMP supply planning and logistics of importing and ordering
• Contribute to planning budgets and budget tracking
• Ensure preparation of regulatory submissions on time in coordination with the Regulatory Department
• Ensure and coordinate IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study
• Maintain effective communication with other members of the clinical team and management
• Mentor and help manage CRAs and CSAs, providing honest and effective feedback to team members
• Ensure SOPs and Training Plans/Quality Plans/Data Safety Monitoring Plans are adhered to, including monitoring report timelines and review
• Provide internal and external education related to clinical trials
• Think critically to problem solve and improve upon processes
• Locate and assess the suitability of clinical trial sites and vendors
• Liaise with doctors/consultants/investigators on conducting the trial, as appropriate
• Oversee set-up of the study clinics, including ensuring each clinic is prepared for success
• Manage CRA monitoring and, if needed, monitoring of the trial throughout its duration according to the data safety monitoring plan (SQV/SIV/IMV/COV)
• Oversee or as needed complete verification of data, plan data audits and oversee database lock activities according to SOPs
• Provide input to Clinical Systems as requested by Clinical Systems Dept.
• Travel as project needs require

Specific Responsibilities:

• Leads activities on multiple clinical protocols and assists in managing CRAs and CSAs supporting regional monitors, Investigators and Site Staff
• Lead team meetings with sites and MPBC as appropriate
• Facilitates the exchange of information within the Clinical Operations Department as well as other Departments at MPBC and external groups including CRAs, Medical Monitors, Department Heads, CRA’s, Site Staff, Data Management, Finance, Logistics, Adherence Raters, Independent Raters and other collaborators
• Provide leadership in the creation of study training or other formal training at site and at the study team level, providing ongoing training as needed
• Attends, makes presentations and provides training in GCP/ICH/FDA/SOP at Initiation/investigators/site meetings, as appropriate
• Create and carry out CAPAs as appropriate
• Guide clinical trial sites in obtaining schedule I (Class A) prescriber license, coordinating authorisation submission process for sites, ensuring licenses are kept current
• Coordinate with CRAs and sites through the drug storage, packaging and import logistics
• Leads the preparation of study related documents through finalisation
• Leads responding to regulatory or ethics committee comments to gain approval
• Ensure successful study recruitment through creative trouble shooting
• Ensures the quality of study data by reviewing data listings and findings, managing data entry, ensuring MM and site review of data, completing data base lock tasks
• Facilitates data analysis and identifies study data trends
• Ensure data cleaning timelines are communicated to staff and sites to meet data deadlines for Annual Reports, IBs, DSMB meetings, etc.
• Organizing audits according to SOPs and Quality Plans
• Escalates and leads resolution of compliance issues at assigned centres
• Assist in the review of trends in monitoring findings – taking the lead on resolution of compliance issues at study sites with CRAs
• Ensure monitoring visits occur on time, reports are completed, reviewed, signed off and filed on time
• Ensure protocol deviations are collected and assessed for compliance issues, providing or ensuring re-training and escalation where needed
• Maintain oversight and accountability of an inspection-ready eTMF
• Maintains accurate and up-to-date information of project management and tracking systems
• After study conclusion ensures central archiving of the Trial Master File and all study related documents according to SOPs, national law and ICH-GCP requirements
• Assist as needed in developing timelines and action items for realization of the analysis plan and preparation of the study report
• Participates in the management of resources, timelines, CDPs and budgets
• Participates in the identification and selection of CROs, new hires or contractors, as needed
• Assist in writing SOPs, policies and procedures, as needed.

Interested and qualified candidates are encouraged to send their CV to paul.bezodis@mapsbcorp.com

About MAPS Europe and MAPS Public Benefit Corporation (MAPS PBC)

MAPS Europe and 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 Europe and 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 values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS strives to establish a supportive, equitable and accessible work environment.