What You’ll Do:

We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products.

 Responsibilities:

• Manage and lead all aspects of clinical trial data management activities from study start-up to database lock.
• Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs.
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle.
• Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts.
• Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock.
• Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers.
• Identify Protocol Deviations
• Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects).
• Participate in the development and review of clinical study protocols, case report forms (CRFs), and clinical trial documentation.
• Provide support for regulatory submissions, audits, and inspections related to clinical trial data management.
• Stay current with industry standards, best practices, and regulatory requirements related to clinical data management.

Qualifications:

• Bachelor’s degree in life sciences, computer science, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency in Medidata Rave electronic data capture (EDC) system..
• Strong understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements (e.g., FDA, EMA), and industry standards (e.g., CDISC).
• Excellent communication, organizational, and problem-solving skills.
• Ability to work effectively in a fast-paced, cross-functional team environment.
• Attention to detail and commitment to data quality and integrity.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA.