Clinical Trial Master File Specialist

4 days ago


Cambridge, Massachusetts, United States Bicycle Therapeutics Full time
Job Title: Clinical Trial Master File Specialist

About the Role:

We are seeking a highly skilled Clinical Trial Master File Specialist to join our growing team at Bicycle Therapeutics. As a Clinical Trial Master File Specialist, you will be responsible for supporting the development and implementation of our eTMF system, ensuring that our clinical trial records are accurate, complete, and compliant with regulatory standards.

Key Responsibilities:

- Collaborate with cross-functional teams to ensure that our eTMF system is implemented correctly and meets regulatory requirements
- Develop and maintain TMF plans, indexes, and other related documents
- Perform quality control reviews of internal and CRO-managed eTMFs
- Identify and escalate quality issue trends
- Provide training and support to internal and external study teams on eTMF best practices

Qualifications:

- Bachelor's degree in a related field (e.g., life sciences, healthcare administration)
- Minimum 2 years of experience in clinical trials, preferably in a TMF operations or quality assurance role
- Strong understanding of eTMF systems, GCP guidelines, and regulatory requirements
- Excellent communication and project management skills

Benefits:

- Competitive salary and bonus structure
- Comprehensive benefits package, including medical, dental, and vision insurance
- 401(k) plan with 4% company match
- Flexible working environment and opportunities for professional growth and development

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