Senior Clinical Trial Manager

Who We Are: 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.

What You’ll Do: We are seeking an experienced Senior Clinical Trial Manager to lead and oversee the execution of clinical trials focused on advancing our neurological and psychiatric pipeline. Reporting to the VP, 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 Senior 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)
• Evaluates, selects, and ensures 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 needs
• Anticipates, recognizes, and manages issues/risks and recognizes the need to seek assistance from or inform Senior Management
• Understands when decision making can occur at the study team level versus when there is a need for escalation to Senior Management
• Analyzes clinical study and investigative site risks and implements corrective actions, where required
• Drives quality-by-design efforts to proactively identify and manage risks to trial quality and ensure MapLight inspection readiness at all times

Study Management and Oversight

• Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc
• Coordinates the development and distribution of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
• Partners with Global Supply Chain (Technical Operations) team to provide oversight of the applicable study drug(s), including supply projections, distribution, labeling and destruction
• Tracks clinical study metrics and reports to management on study(ies) run by MapLight
• Plans, 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 activities
• Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
• Provides guidance and shared learning within and across teams
• Mentors more junior Clinical Operations staff member(s)
• Champions operational best practices and seek opportunities for efficiencies within the Clinical Operations group
• Performs administrative functions and additional duties as assigned and appropriate

Qualifications:

• Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered. (6+ years in the biotech /pharmaceutical industry /clinical trial management area)
• Thorough understanding of the drug development process with sound knowledge of ICH-GCP
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
• Shown technical, administrative, problem solving and project management experience
• A solutions-oriented approach to working cross-functionally with a team of individuals to deliver stated goals and objectives

Travel:

• Ability to travel up to 15%

 

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.