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. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at http://www.mapsbcorp.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, 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.
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 CPM is responsible for managing, implementing and maintaining oversight of clinical studies and assigned clinical staff in a team setting over multiple protocols with minimal supervision. CPM responsibilities include: Assist in planning and managing assigned clinical study protocols from conception through database lock and clinical study reporting; manage and oversee CTLs/CRAs/CSAs, delegate/assist CRAs/CSAs in the preparation, review, and finalization of study protocols, plans, documents, and tasks in line with required timelines; participate in identifying, developing, and implementing departmental proficiencies for study management, oversee task management of assigned clinical trial sites; communicate clinical program timelines to clinical study team, leadership, and external parties; coordinating clinical supplies, budgets and contracts; and proactively identify and/or escalation of study and staff issues/risks and recommends/implements solutions.
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. Priority is placed on applicants based in the pacific time zone.
Full time, exempt, salaried position. Must be available during normal business hours for a California-based company. Occasional night and weekend hours may be required. The exact schedule may be arranged upon hire.
- A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor’s degree preferred. A minimum 8 years CRA experience or equivalent experience and 2 years of clinical trial management experience or equivalent.
- Knowledge of medical practice/techniques and terminology. Proficient knowledge of clinical research study design and process. Knowledge of U.S. regulations governing clinical trials, demonstrated ability to adhere to GCP and regulatory standards. Demonstrated experience preparing, gaining approval and managing clinical protocols.
- Oversee the preparation and finalization of protocol, protocol related and quality documents. Liaise with departmental leads, leadership, and Medical Monitor to coordinate input in study design, internal team and site study planning, quality/risk mitigation and timeline management.
- Collaborates with Project Manager to develop and maintain accurate and up-to-date information of project management and tracking systems in line with company timelines
- Manages timelines and delegate the preparation of study related documents through finalization; ensuring prioritization and resourcing needs are clearly communicated cross functionally, as required
- Assists in timeline development, with the Project Manager and leadership, to lead and facilitate data analysis and identify study data trends for assigned programs
- Ensure data cleaning timelines are communicated to staff and sites to meet data deadlines for Annual Reports, IBs, DSMB meetings, database lock etc.
- Oversee and manage timelines associated with development, review, and finalization of ICF, CRFs, Source Records, Study Reference Manual, Quality Plans, Risk Assessment (RACT) etc. working cross functionally amongst teams and with departmental leads to maintain consistency and ensure completion in line with required company timelines with minimal oversight using project management tools of the organization
- Oversee and review creation, implementation and resolution of CAPAs.
- Provide leadership in the creation of study training or other formal training at site and study team level, providing ongoing training as needed
- Assist with responding to regulatory or ethics committee comments to gain approval
- Support forecasting IMP requirements with CMC and Project Management department and manage the coordination of IMP supply logistics importing and ordering with CTLs/CRAs/CSAs
- Oversee CTLs/CRAs and sites through the drug storage, packaging and import logistics, with minimal oversight required
- Assist leadership in planning budgets and budget tracking and contract execution
- Participates in projections on and manages the resources, timelines, CDPs and budgets, specific to assigned trials with minimal direction required
- Approve site payments and invoices providing coding for processing in alignment with budgets
- Oversee set up of the study clinics with minimal oversight, including ensuring each clinic is prepared for success
- Effectively lead and communicate with other members of the clinical team and management; ensuring to escalate/implement executive directives accordingly and in line with timelines
- Provide clear direction along with honest and effective feedback to team members, ensuring impeccable agreements across study teams
- Manage study team and site compliance to ensure SOPs and Training Plans/Quality Plans/Data Safety Monitoring Plans are adhered to, including monitoring report timelines and review
- Manage CRA and CTL rate of monitoring and, if needed, monitoring of the trial throughout its duration according to the data safety monitoring plan (SQV/SIV/IMV/COV) ensuring monitoring visits occur, reports are completed, reviewed, signed off and filed according to SOPs and plans
- Ensure protocol deviations are collected and assessed for compliance issues, providing leadership to CRAs ensuring re-training and escalation where needed; Monitor and identify level trends requiring cross-functional process change and escalating to leadership, as required
- Provide direction and support to encourage critical thinking and problem solving amongst the clinical study team to improve upon processes and implement efficiencies promoting a growth mindset
- Oversee the review of trends in monitoring findings – providing leadership to CRAs on resolution of compliance issues at study sites; monitor and identify study level trends requiring cross-functional process change and escalating to leadership, as required
- Ensure successful study recruitment through creative trouble shooting using tools at MPBC reporting back to leadership
- Manage CTL/CRAs/CSAs oversight of eTMF; ensuring proper compliance with required review timelines, SOP, system and study staff training requirements
- After study conclusion ensures central archiving of the Trial Master File and all study related documents according to SOPs, national law and GCP-ICH requirements
- Ensures the quality of study data by anticipating potential data issues/risks and working with clinical study team to implement/escalate as needed; reviewing data listings and findings, overseeing data entry progress, ensuring team, Medical Monitor and site review of data
- Proactively identify potential audit readiness activities internally and at sites
- Oversee or as needed complete source verification of data, plan data audits and oversee database lock activities according to SOPs
- Provide direction and input on Clinical Systems as requested by Clinical Systems Dept.
- Evaluates and identifies processes and system improvements to ensure timely and effective study management and completion
- Liaise with doctors/consultants/investigators on conducting the trial
- Lead team meetings with sites and MPBC as appropriate
- Assists in planning and facilitating the exchange of information within the Clinical Development Department as well cross functionally with other Departments providing input and updates to study timelines, dashboards, kick off meeting and debriefing meetings
- Oversee training plan implementation, mentor direct reports
- Supports the leadership in analyzing performance, identifying root causes of non/poor performance and implementing corrective actions, while noting positive aspects and opportunities to share across teams for continuous improvement
- Reviews factors related to evaluation, development, and retention of the clinical research operations staff, establishing performance goals by role
- In collaboration with leadership, plans and monitors the workload of clinical operations staff (Employees, In-sourced and Contractors)
- Builds the team by proper communication and motivation leading by example, committing to the use of The Conscious Leadership Group (CLG) principles in day-to-day interactions and enforcing company values and mission
- Assess and review team communication plans and meeting schedules to support effective and beneficial communication
- Informs leadership of issues that can jeopardize business relationships with the Sponsor
- Monitors and enforces compliance with systems, processes and policies and all applicable regulations
- Problem Solving - Identifies and resolves problems in a timely manner evaluating alternative solutions. Works well in group problem solving situations and uses reason even when dealing with emotional topics.
- Interpersonal Skills - Focuses on solving conflict. Listens to others without interrupting and keeps emotions under control while remaining open to others' ideas.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations. Listens and gets clarification.
- Grit - Goal-oriented, purpose-driven and willing to put in the work. Ability to take a challenge and run with it with an open mind constantly finding ways to succeed.
- Written Communication - Writes clearly and informatively. Varies writing style to meet needs. Able to read and interpret written information.
- Teamwork - Balances team and individual responsibilities. Exhibits objectivity and openness to others' views. Contributes to building a positive team spirit and puts success of team above own interests.
- Quality Management - Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
- Business Acumen - Understands business implications of decisions and aligns work with strategic goals.
- Cost Consciousness - Works within approved budget and conserves organizational resources.
- Diversity - Shows respect and sensitivity for cultural differences supporting a diverse workforce.
- Ethics - Treats people with respect and keeps commitments. Inspires the trust of others and works with integrity and ethically. Upholds organizational values.
- Organizational Support - Follows policies and procedures. Completes tasks correctly and on time supporting the organization's goals and values.
- Judgment - Displays willingness to make decisions and exhibits sound and accurate judgment. Supports and explains reasoning for decisions. Includes appropriate people in decision-making process and makes timely decisions.
- Motivation - Sets and achieves challenging goals. Demonstrates persistence and overcomes obstacles. Measures self against standard of excellence taking calculated risks to accomplish goals.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Adaptability - Adapts to changes in the work environment and manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events with a high level of comfort with ambiguity.
- Dependability - Follows instructions and responds to management direction. Takes responsibility for own actions and keeps commitments. Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Undertakes self-development activities and Seeks increased responsibilities. Asks for and offers help when needed.
- Innovation - Displays original thinking and creativity meeting challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas.
Exempt, salaried position, not eligible for overtime.
Salaried compensation commensurate with experience. Full benefits package included.