Job Summary: TheCTA is responsible forsupporting the Clinical program teams and may assist the teams across multipleclinical studies. The CTA would also participate in broader clinical operationsactivitiesand initiatives such as the development and refinement of new processes.

Responsibilities:

Clinical Study and Program Support ~70%

• Support clinical study teams in the delivery of key milestones throughout the clinical study lifecycle
• Assistance with clinical study budgets and contract tracking
• Coordinate team review and finalization of key study documents
• Provide meeting logistics,documentation, and follow-up
• Develop & maintain trackers, dashboards, and presentations
• Administer system access for site users for various study systems
• Opportunities for vendor interaction and increased responsibilities based on experience.

Document Management ~20%

• Maintain sponsor TMF documents and ensure appropriate study level TMF processes are in place with clinical vendors including TMF Review Plans
• Coordinate and conductTMF reviewswith study personnel according to TMF Plans
• Ensure complete and inspection readyeTMFsthroughout the duration and at the end of clinical studies

Clinical Study Budget and Contract Support ~10%

• Develop and maintain tracking system to facilitate study contract and budget oversight and collaboration between clinical operations and finance
• Provide input into vendor proposals and evaluate for potential efficiencies.

Attributes:

• Works collaboratively and proactivelyseeking out ways to facilitate the conduct of clinical studies.
• Ability to work effectively with minimal structure as well as determine when structure is needed and develop related procedures.
• Motivated to work in a small organization to develop treatments for difficult, rare diseases.
• Drive to learn more about clinical development operations and cross-functional areas in a fast-paced team environment.

Qualifications

• BA/BS preferred; can be substituted with more years of experience.
• At least 2 years of experience supporting clinical studies administratively or as a study coordinator; experience with a pharmaceutical or biotech company is preferred; additional experience in other related fields or positions is a plus.
• Savvy with IT systems including standard MS software applications. Comfortable learning new systems.
• Good general GCP knowledge.
• Excellent interpersonal, organization, problem solving, and communication skills.
• Able to be in-office (Lexington, MA) 3 days/week

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