Clinical Trial Operations Specialist

TalentCraft; Waltham (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

TalentCraft in Massachusetts seeks a highly motivated CTA to provide administrative and operational support to Clinical Operations. You will coordinate study logistics, maintain trackers, and support eTMF reviews, ensuring documents are complete and versioned.

Ideal candidates have 3+ years of biotech or life sciences administrative experience, strong communication, and proficiency in MS Office. Familiarity with Veeva TMF and regulatory standards is a plus.

Qualifications

• Bachelor’s degree in administrative, science or medical areas is required or a plus.
• 3+ years of administrative experience in biotech/life sciences, healthcare or clinical study management.
• Demonstrated ability to work independently and as part of a team with excellent organizational skills.
• Strong verbal and written communication skills; proficient in MS Office and data tracking.
• Knowledge of Veeva TMF and regulatory requirements (ICH-GCP, FDA) is a plus.
• Proven multi-tasking and project management capabilities.

Responsibilities

• Organize and maintain agendas and meeting minutes for internal and cross-functional meetings.
• Coordinate, track, and manage logistics to support studies (eTMF review, study plans).
• Update internal trackers and create ad-hoc reports and presentations.
• Maintain study files, perform periodic document reconciliations, ensure version control.
• Create and maintain study personnel contact lists and KOLs by disease indication.
• Assist with study document reviews (protocol, IB, ICFs).
• Support external meetings: outreach, scheduling, CDAs, contracts, travel, agendas, minutes.

Skills

Administrative experience

Communication

Organization

Microsoft Office

Veeva TMF knowledge

Project management

Team collaboration

Multitasking

Education

Bachelor's degree in administrative, science or medical areas

Tools

SharePoint

SmartSheet

Microsoft Office Suite

Job description

TalentCraft in Massachusetts seeks a highly motivated CTA to provide administrative and operational support to Clinical Operations. You will coordinate study logistics, maintain trackers, and support eTMF reviews, ensuring documents are complete and versioned.

Ideal candidates have 3+ years of biotech or life sciences administrative experience, strong communication, and proficiency in MS Office. Familiarity with Veeva TMF and regulatory standards is a plus.