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Senior Clinical Trial Associate (Sr. CTA)

External
maplighttherapeutics logoMaplighttherapeutics · Burlington, MA
$115K–$140K/yrFull-timeOn-site1mo ago
Clinical TrialsComplianceDocumentationGCP
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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

Requirements

  • 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.
  • Salary Range
  • $115,000 - $140,000 USD

Benefits

Dental insuranceVision insurance401(k)Paid time offFlexible scheduleEquity / stock optionsPerformance bonusParental leave

Additional Information

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.


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