Senior Clinical Trial Associate (Sr. CTA)

MapLight Therapeutics•Burlington, MA

6d•Hybrid

About The Position

MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. We utilize cutting-edge technologies such as optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies for psychiatric symptoms. The Senior Clinical Trial Associate (Sr. CTA) will support Clinical Operations and project teams, offering significant responsibility and involvement across all phases of clinical projects. This role requires adaptability, ownership of tasks, problem-solving skills, and the ability to see activities through to completion.

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.
Knowledge of ICH-GCP is a plus.
Strong interpersonal, organizational, and planning skills.
Excellent verbal and written communication skills.
Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly.
Ability to identify areas for efficiency across studies in the spaces that the position is responsible for.
Ability to travel up to 35%.

Responsibilities

Interact directly with Clinical staff (CRAs, trial managers), site staff, and vendors (U.S. and worldwide) to provide support in project-specific tasks and overall clinical trial management.
Directly support Operational Leaders, Clinical Leaders, and Clinical Trial Managers.
Maintain and manage requests for access to and deactivation of study systems users.
Coordinate materials (PowerPoint presentations, templates, outstanding essential document listings, etc.) for internal and external meetings, including requests from external consultants and suppliers.
Distribute safety alerts and relevant documents as required.
Maintain and update study team and vendor contact information.
Assist in the planning, organizing, and execution of study-specific meetings, including writing and distributing agendas, minutes, and regular updates.
May participate in reviewing, formatting, and finalizing study-related templates, plans, and manuals.
Assist with maintaining clinical trial insurance.
Address questions, issues, or requests from the Clinical Research Organization (CRO)/study team and route them to the appropriate individual within the organization for resolution.
May participate in clinical data review as required.
Ensure the completeness of documents managed in the Trial Master Files (TMF), performing ongoing reviews to assure documentation quality 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 to support Clinical Operations and individual studies.
May analyze or update data associated with the trackers.
Perform other duties as assigned to support Study Team Leads and Operational Team Leads.