What You’ll Do:

Reporting to the VP of Clinical Operations the Lead Clinical Research Associate will oversee an assigned MapLight study monitoring team to ensure monitoring quality and excellence in line with MapLight’s Mission, Vision, and Values. This role will maintain site management and monitoring responsibilities for assigned sites in addition to study team level work. This role will collaborate closely with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment.

Responsibilities:

• Lead and manage a team of Clinical Research Associates.
  • Provide line management for CRAs inclusive of performance management and career development.
  • Ensure CRAs are trained and maintain compliance with internal procedures and processes and regulatory requirements (GCP).
  • Support the Clinical Operations study team with CRA resourcing.
• Maintain site management and monitoring responsibility for at least one site for the assigned study(ies).
  • Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits in accordance with MapLight SOPs and procedures, regulatory requirements and industry guidelines and best practices (ICH GCP).
  • Support the study team in meeting study milestones (site activation, DSMB meetings, database lock, etc.).
  • Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues.
  • Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
  • Serve as the main MapLight point of contact for Investigator sites to support protocol compliance, streamlined communications, timely responses to site staff needs, and training needs.
  • Support the study team and Investigator sites during inspections or audits, as needed.
• Support the study team(s) in development of study-specific monitoring procedures.
  • Develop and maintain the study monitoring plan, templates, and tools.
  • Recommend and implement appropriate monitoring strategy based on study design, recruitment goals and the needs of the study.
  • Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring.
• Act as a core member of the cross-functional study team.
  • Participate in study team meetings as a subject matter expert on monitoring processes.
  • Take a proactive and innovative approach to risk and issues management as related to monitoring quality or strategy.
  • Recommend and implement process changes related to monitoring to support study goals and timelines.
  • Support the study team in the integration of the monitoring function in study management (feasibility, site activation, site communication, risk management, etc.)
  • Support the study team and Investigator sites during inspections or audits, as needed.
  • Accomplish other tasks as assigned.
• Provide oversight of study monitoring
  • Review monitoring visit reports to ensure MapLight quality standards are met.
  • Review Key Performance Indicators for assigned CRAs to ensure high performance and compliance with requirements.
  • Perform oversight visits and co-monitoring visits to ensure quality monitoring.
• Support development and process improvement for the MapLight monitoring function.
  • Support development and revision of SOPs, processes, templates, tools, and plans with the aim of continual improvement and streamlining.
  • Maintain a forward-thinking approach to monitoring process to support department and corporate growth and change.
  • Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.
• Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.

Qualifications:

• Bachelor’s degree in a relevant field or RN; approximately 7+ years in the clinical trial industry with at least 5 years of clinical monitoring including complex therapeutic areas, in-patient trials, and blinded trials. (Recent CNS and/or neuropsychiatry, specifically in-patient schizophrenia and Alzheimer’s disease psychosis experience, strongly preferred.)
• Experience working in small/emerging biotech a plus
• Experience managing a clinical monitoring team at a pharmaceutical or biotech company or CRO.
• Demonstrated ability serve as a role model and mentor to more junior clinical staff.
• Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
• Ability to engage collaboratively with internal and external stakeholders in a professional manner.
• Strong interpersonal, oral, and written communication skills.
• A self-starter with the ability to work independently and proactively.
• Willingness to be a “team player” and take on additional responsibilities as requested.
• Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• High attention to detail and focus on quality and compliance in all aspects of assigned work.
• Experience working in various clinical software systems (CTMS, eTMF, RIM).
• Proficiency with Word, Excel, PowerPoint, and Microsoft Office.
• Ability to travel independently by air, car and/or train. Location near a major airport preferred.

Travel:

• Position will require up to 30-40% travel with potential to be higher at times of peak study activity. Additional periodic travel for meetings is expected.

What You’ll Do:

The Senior Clinical Trial Associate (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end. 

Responsibilities:

• Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
• Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:
• Maintain and manage requests for access to and deactivation of study systems users.
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
• Distribute safety alerts and relevant documents, if required
• Maintain and update study team and vendor contact information
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
• May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
• Assist with maintaining clinical trial insurance
• Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
• May participate in clinical data review, as required

• Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines

• Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review
• Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
• Other duties as assigned to support Study Team Leads and Operational Team Leads

Qualifications:

• Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered.
• Minimum 2+ years in the biotech /pharmaceutical industry /clinical trial management area
• Competency of the drug development process with knowledge of ICH-GCP is a plus
• Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
• Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.

Travel:

• Ability to travel up to 35%

Location: 3 day hybrid in office in Burlington, MA

Maplight is anticipating two Ph2 readouts in Q3 2026

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

What You’ll Do:

MapLight is looking for a dynamic and experienced Senior Specialist, Clinical Business Operations.  Reporting to the Executive Director, Clinical Operations, the Senior Specialist will be responsible for supporting all aspects of clinical business operations, including vendor selection, contracts, budget management and performance metrics. The ideal candidate will streamline operational procedures across multiple projects to improve timelines and organization of data.

Responsibilities:

• Vendor selection; including review and analysis, budget negotiations, development, and execution.
• Manage the Request for Proposal (RFP) process. This includes:
  • Work with Clinical Trial Managers (CTM) and Clinical Scientific Leads to develop outsourcing strategy including range of vendors and timelines for award (i.e. schedule a vendor outsourcing strategy meeting).
  • Use the RFP template to customize to each study.
  • Create a draft of the RFP for review by the study team.
  • Communicate with vendors the RFP timelines and milestones and coordinate feedback to questions/answers.
  • Maintain the internal RFP timelines and milestones.
  • Following award, be the point of contact to receive the scope of work and budget grid from vendor.
  • Coordinate the review and consolidate the internal study team’s (and finance) questions and comments regarding the budget to the vendor.
  • Coordinate contract review and Coupa entry of budget.
  • Initiate a warm transfer to the operations team.
• Manage MapLight’s review of all site budgets and contracts. This includes:
  • Lead discussions with vendor and CTM to develop study budget and acceptable ranges.
  • Forecast site contract review timelines as they related to study start up with assistance from the study CTM.
  • Laise with the Legal Department to ensure MapLight specific site contract template with fall back language is acceptable.
  • Coordinate with CRO/vendor for process of escalation language to MapLight.
  • Coordinate with study team on internal process for triage of contract language and budget requests.
  • Provide and/or track contract status updates/reporting.
  • Ensure all executed site contracts are filed in the designated area within MapLight.
• Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality Agreements, Master Services Agreements, Work Orders, Amendments, Change Orders, and any other type of contracts) needed for clinical studies.
• Actively managing other clinical financial obligations.
• Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner in collaboration with Legal, Finance and other internal stakeholders as needed to finalize.
• Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships.
• Innovate and maintain tracking systems and metrics, translating complex data into actionable insights for project and program advancement.
• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understand relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll-up your sleeves and get the job done.

Qualifications:

• Bachelor’s Degree or equivalent education required, preferably in Life Sciences, Finance, or Business Administration.
• A minimum of 3 years experience with outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.
• Experience working with the biotech/pharmaceutical industry at a CRO or sponsor company preferred.
• Experience working with key Clinical Operations stakeholders.
• Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
• Demonstrated strong analytical skills.
• Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
• Must be flexible and adaptable to changing project priorities, work assignments and deadlines.

 Location: 3 day hybrid in office position in Burlington, MA. 

MapLight is anticipating two Ph2 readouts in Q3 2026

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

What You’ll Do: Reporting to the VP of Clinical Operations, the Sr. Director of Clinical Monitoring and Operational Systems plays an integral role in the strategic development, oversight, and execution of global clinical monitoring and operational systems across MapLight’s entire clinical trial portfolio.  This role will develop forward‑thinking approaches to strengthen site relationships, guide the oversight of monitoring activities, and reinforce the organization's standing as a dependable and collaborative study sponsor.  Close collaboration with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Data Management and Clinical Compliance and Quality as well as external CRO and vendor partners is essential to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. Applicants should be outstanding team members with the ability to effectively lead a team and to communicate with and influence both internal and external stakeholders with a passion for positive site relationships and clinical participant experiences.

Responsibilities:

• Ensure global clinical monitoring is executed with high standards of quality and consistency while maintaining compliance with GCP regulations whether monitoring done by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs).
• Oversee Lead CRAs, providing support and guidance for their management of monitoring teams; creates a culture of continuous learning for all levels of clinical monitoring team members.
  • Conducts oversight monitoring visits and/or co-monitoring visits where required
• Enhance the framework for clinical site monitoring and site management strategies and activities. Partners closely with Trial Managers and Data Management leaders in aligning these strategies
• Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems and team members.  
• Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy, with the development and maintenance of SOPs, processes, tools and templates. Partner closely with QA to maintain a compliance framework.
• Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs) for implementation with monitoring plans, eTMF inspection readiness, and processes. Lead where appropriate, and participate and support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight
• Grow and develop team members in the clinical monitoring and operations systems team. Assist in the development of career pathways and standardized functional training.
• Represents the monitoring and clinical operations system functions in senior management meetings, where applicable. Supports the LCRAs, in partnering with Clinical Leads and Trial Managers to ensure appropriate monitor resourcing for clinical studies.

Qualifications:

• Bachelor’s degree in a relevant field; a minimum of 12 years in the clinical trial industry with at least 5 years experience onsite clinical monitoring
• A minimum of 5 years providing global trial monitoring oversight with direct management of monitors.
• Experience managing FSP/CRO monitoring teams and developing monitoring quality metrics, KPIs, with demonstrated focus on building processes, standardization and efficiencies.
• Demonstrated experience with a variety of CTMS and eTMF platforms
• Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a willingness to teach others as evidenced by a collaborative work style.
• Competency in technical systems that improve efficiencies (ex. Power BI).
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• Deep working knowledge of ICH‑GCP, FDA, EMA, and other global regulatory requirements, and clinical operational standards.
• Demonstrated ability to attend to detail, make effective presentations and work independently.
• Ability to travel independently by air, car and/or train.

Travel:  Position may require up to 30% travel in an annual year

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.