Clinical Trial Manager
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
We are seeking an experienced Clinical Trial Manager to lead and oversee the execution of clinical trials focused on advancing our neurological and psychiatric pipeline. Reporting to the Associate Director, Clinical Operations, this role is critical in managing the operational aspects of our clinical programs, ensuring they are conducted efficiently, on time and in compliance with regulatory requirements.
Responsibilities :
- Managing all aspects of study progress (from protocol development and planning to study close-out, including supporting the development of clinical study reports). The CTM assures adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, ICH GCP guidelines, and MapLight SOPs
- This role is responsible for collaborative and effective management of cross-functional study team activities, as well as communication with and management of multiple external vendors and stakeholders (e.g., CROs, central labs, IRBs / ECs, and other external partners)
- Participates in the evaluation, selection, and ensures the appropriate oversight of Contract Research Organizations (CROs) and other external vendors
- Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
- Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables (subject enrollment, clinical monitoring activities, clinical site compliance and data metrics)
- Leads the clinical study budgeting and site contracting process with the legal team
- Provides input to the development of study-level budget(s) and demonstrates accountability for the management of assigned clinical study budget(s) by :
Tracking vendor performance against scopes of work, contracts, and invoices to ensure consistency between work performed and contractual agreement(s)
Facilitating review of study-level scopes of work, invoices, change request forms, and change orders to ensure consistency with study progress and / or evolving study needsAnticipates, recognizes, and manages issues / risks and recognizes the need to seek assistance from or inform Senior ManagementAnalyzes clinical study and investigative site risks and implements corrective actions, where requiredDrives quality-by-design efforts to proactively identify and manage risks to trial quality and ensure MapLight inspection readiness at all timesStudy Management and Oversight :
Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etcCoordinates the development, review, and distribution of critical study documents, including ICFs, operational documents / plans, study reference documents, study newsletters, and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as neededAssists with Global Supply Chain (Technical Operations) team to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destructionTracks clinical study metrics and reports to management on study(ies) run by MapLightPlans, facilitates, and monitors training at investigator meeting(s), kick-off meeting(s), and various CRO (or other vendor) meeting(s)Performs quality assurance checks (e.g., reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site / CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)Coordinates Independent Safety Committees, when applicable, including collecting confidentiality agreements, contracts, and conflict of interest forms from Committee Members, reviewing Safety Charter, planning and scheduling meeting(s)Supports and collaborates with QA during vendor / site selection and vendor / site / study audit activitiesMentors more junior Clinical Operations staff member(s) in study management skills and tasksPerforms administrative functions and additional duties as assigned and appropriateQualifications :
Bachelor's degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered. (4+ years in the biotech / pharmaceutical industry / clinical trial management area)Thorough understanding of the drug development process with sound knowledge of ICH-GCPStrong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skillsShown technical, administrative, problem solving and project management experienceA solutions-oriented approach to working cross-functionally with a team of individuals to deliver stated goals and objectivesAbility to travel up to 15%Location : This is a hybrid position with three days per week onsite at our office in Burlington, MA.
