Senior Clinical Trial Associate (Sr. CTA)

Posted Yesterday
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Burlington, MA, USA
In-Office
115K-140K Annually
Senior level
Biotech
The Role
Support clinical operations across all trial phases: manage TMF and study documents, coordinate systems access, liaise with sites/CROs/vendors, prepare meeting materials and minutes, maintain trackers, assist with clinical trial insurance and data review, and ensure compliance with SOPs and ICH-GCP.
Summary Generated by Built In

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:

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.


Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

Salary Range
$115,000$140,000 USD

EEOC Statement: MapLight Therapeutics 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.

Skills Required

  • Bachelor's degree in a relevant subject area (or combination of education and applicable experience)
  • Minimum 2+ years in the biotech/pharmaceutical industry or clinical trial management
  • Competency in the drug development process and knowledge of ICH-GCP
  • Strong interpersonal, organizational, planning, and excellent verbal and written communication skills
  • Proactive self-starter with ability to take ownership of tasks and drive execution
  • Ability to travel up to 35%
  • Willingness to work hybrid schedule (3 days in-office) in Burlington, MA
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The Company
HQ: Palo Alto, CA
55 Employees
Year Founded: 2018

What We Do

Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

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