Clinical Data Specialist

Clinical Data Specialist

Location: Acton, MA

Pay Rate: $57.50 per hour

We are seeking an experienced Clinical Data Specialist to support clinical data management activities across multiple studies. This role plays a critical part in ensuring data accuracy, regulatory compliance, and successful execution of the clinical data management lifecycle within a fast-paced research environment.

Key Responsibilities:

• Create and review study-specific Case Report Forms (CRFs) in collaboration with clinical teams.
• Contribute to standardized CRF library development for consistency across studies.
• Support Electronic Data Capture (EDC) database builds, validation, and User Acceptance Testing (UAT).
• Develop and review key documentation, including Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), annotated CRFs, edit check specifications, and UAT plans.
• Perform data review, generate and resolve queries, and prepare datasets for database locks and study archival.
• Produce study metrics, data trend reports, and query summaries.
• Train investigators and site coordinators on EDC systems and CRF guidelines.
• Manage EDC system access for sponsor and site users.
• Ensure compliance with Good Clinical Practices (GCP), FDA regulations, and applicable ISO standards.

Qualifications:

• Bachelor's degree strongly preferred.
• Minimum 2+ years of clinical data management and EDC experience.
• Strong knowledge of GCP, FDA regulations, and clinical trial best practices.
• Proficiency in MS Windows-based applications and multiple EDC platforms.
• Excellent organizational, communication, and time-management skills.
• Ability to manage multiple projects independently in a dynamic environment.
• Up to 5% travel required.

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

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