Clinical Program Operations Manager

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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

The Clinical Program Operations Manager (CPOM) will report to the Director of Clinical Operations. The CPOM will work 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 CPOM is responsible for managing and maintaining oversight of clinical teams and studies in a team setting across multiple protocols. CPOM responsibilities include: Managing assigned study personnel as the CTLs/CRAs and CSAs manage sites and study protocols from conception through database lock, including clinical study reporting. Directly managing and mentoring CTLs/CRAs/CSAs (3-5 reports); contributing to protocol and document development, including amendments, task management of staff- CTLs/CRAs/CSAs, communicating clinical program timelines, coordinating clinical supplies, budgets and processing invoices. Reviewing SOPs and Work Instructions, oversight of clinical input and uses of clinical systems (CTMS, eTMF, etc.), assisting with contract and site budget negotiations. Suitable candidates are able to work well in a fast-paced environment and excel at organizing and managing lots of information virtually. 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. 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 and Bay Area who can work a percentage of time in office in Oakland. The MAPS PBC headquarters office is located in Santa Cruz, CA. Travel will be required.

 

Hours

Full time 40 hours per week. Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday-Friday PST). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

General Responsibilities

 

Cross-functional Representation

Facilitate timely and effective communications of MPBC Leadership decisions and progress, as well as communicating significant decisions and issues (including those of any functional area sub-teams or committees) back to MPBC Leadership. Contribute to the establishment of CDT goals that are aligned with Corporate and Global Clinical Development goals and that clinical sites and other functional teams are executing to optimally achieve those goals. Provides updates on MPBC perspectives and ensure alignment of goals.

Program Planning & Management 

  • Assists in evaluating and implementing departmental strategy
  • Provides strategic input on clinical operations matters (i.e. feasibility, quality, protocol design, study management, participant recruitment, study execution timelines, personnel & site management, and risk mitigation) for assigned clinical trials
  • Escalates issues/obstacles of strategic importance and study quality to the MPBC Leadership team for review, discussion and mitigation planning
  • Coordinates provision of resources required in support of assigned clinical trials
  • Oversees and ensure the timely and quality execution of assigned studies according to the study protocols, study execution plans, and GCP guidelines (including SOPs, ICH, FDA and other health authorities)
  • Ensure study timelines are up to date in coordination with Clinical Program Project Manager
  • Escalation point for any clinical operations issues that have a significant impact on overall study or program timelines, other functions, budget or quality
  • Oversees the development of cross-functional efforts to define enrollment strategies of studies
  • Communicates key study and program metrics to executives and cross- functional stakeholders
  • Contribute to quality initiatives and provide input to clinical systems coordinating with the Systems and Quality Manager

Program Conduct

  • Oversees and provides guidance to the sponsor clinical team and clinical sites as needed, holding them accountable for achieving assigned deliverables within timelines and budget in accordance with quality standards
  • Ensure successful study recruitment thought creative trouble shooting using tools at MPBC reporting back to senior leadership
  • 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
  • Reviews and confirm risk identification and mitigation planning is in place for each clinical site as well as for the overall program
  • Approve site payments and invoices providing coding for processing in alignment with budgets
  • Ensure study budgets are aligned with contracts and payments/invoicing
  • Ensure site contracts are negotiated between Sponsor and the Site and signed off as appropriate to study start
  • Maintains accurate and up-to-date information of project management and tracking systems and timelines
  • Contribute to and review protocols and protocol related documents for consistency across programs, ensuring proper timelines are kept
  • Contribute to IRB and FDA and other regulatory response documents
  • Coordinate with the Training Team to ensure appropriate site staff are available
  • Maintain effective communication and facilitate the exchange of information within the Clinical Department, MPBC staff and external groups including CRAs, Medical Monitors, Department Heads, Site Staff, Data Management, Finance, Logistics, HR, Adherence Raters, Independent Raters and other collaborators
  • Ensure proper clinical trial site oversight
  • Review or ensure monitoring trip reports are reviewed, according to timelines, reviewing status of each of the studies and making any necessary recommendations for contingency planning
  • Oversee set up of study centers, which includes ensuring each center has the trial materials and training on trial-specific industry standards
  • Knowledgeable in, able to train in, manage and, if needed, monitor (from SQV through COV) the trial throughout its duration according to the Data Safety Monitoring Plan
  • Review the trending of monitoring findings (reports/deviations/data listings/communications) taking the lead on resolution of compliance issues at centers including risk mitigation
  • Oversee or as needed complete verification of data, plan data audits and oversee database lock activities
  • Ensures the quality of study data by reviewing or overseeing review of data listings, managing data entry, completion of data base lock and organizing audits
  • Ensure Clinical Operations input and guidance into CTMS set up
  • Provides input to process and SOPs/Work Instruction review/design
  • Identifies and proposes process and system improvements to maintain quality and effective deliverables

People Management

  • Mentor, manage, train, hire and onboard CTLs, CRAs, CSAs and Interns contributing to studies supporting the Clinical Development Program
  • Plans, monitors and manages the workload of assigned clinical operations staff
  • Lead and contribute to departmental and cross-functional improvement activities, ensuring that clinical staff works efficiently, while managing clinical study teams
  • Lead team meetings as appropriate
  • Identifying competencies and skills required, selecting and recruiting staff, defining appraisal, skills, and pathways for potential career path development
  • Collates feedback from the clinical team in order to plan career progression and assess training requirements
  • Builds the team by proper communication and motivation as well as organizing regular meetings
  • Periodically assesses the performance of clinical operations staff based on feedback from Directors and other relevant roles
  • Informs Senior Leadership Team in case of issues that can jeopardize business relationships with the Sponsor
  • Supports the Senior Leadership Team in analyzing performance, identifying root causes of non/poor performance and implementing corrective actions
  • Reviews factors related to evaluation, development, and retention of the clinical research operations staff
  • Monitors and enforces compliance with systems, processes and policies and all applicable regulations
  • Leads by example, living and enforcing company values

 

Minimum Requirements

  • Bachelor’s degree
  • 10 years of Clinical Research experience in the CRO/Pharmaceutical industry
  • Excellent knowledge in developing work organization models
  • Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)

 

Additional Competencies

  • 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 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
  • Be proactive in problem solving
  • Ability to make public presentations and represent MAPS/MPBC at conferences
  • Ability to use the following tools with some training (previous experience a plus): Microsoft Office Applications (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana

 

Compensation

Salary range disclosed upon request. Includes full benefits package.

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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.