Sr. Clinical Data Manager
Boston, Massachusetts, United States
Job Description
Responsibilities:
Requirements:
- Lead clinical data management activities for pivotal trials, ensuring data quality and integrity
- Collaborate with cross-functional teams to support clinical trial data management processes
- Oversee vendor management and ensure compliance with regulatory standards
- Drive development and implementation of data management plans and validation activities
- Coordinate data cleaning and reporting activities to meet project goals
- Support database design, validation, and maintenance for clinical trials
- Ensure adherence to Good Clinical Practice (GCP) and regulatory requirements
- Provide leadership and guidance to data management teams and stakeholders
- ct as Data Management Study Lead for multiple clinical trials
- Manage vendor relationships and ensure timely delivery of data management services
- Develop and maintain critical data management documentation and plans
- Coordinate data transfer setups and validations, ensuring consistency with agreements
- Perform supplemental data reviews and quality checks as per validation specifications
- Participate in study document reviews, including protocols and statistical analysis plans
- Ensure compliance with CDISC standards and clinical research regulations
- Report project status and escalate study-related issues to senior leadership
Requirements:
- Bachelor of Science degree with 10+ years of clinical data management experience
- Proficiency in EDC systems, CDISC standards, and clinical research regulations
- Experience managing multiple CROs/vendors and ensuring data quality
- Strong knowledge of database structures and data visualization technologies
- Excellent interpersonal, organizational, and communication skills
- bility to prioritize tasks and work effectively in a fast-paced environment
- Logical thinking and attention to detail for high-quality data management
- Commitment to maintaining compliance with GCP and regulatory standards.
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Career Focus: Data Management/Data Science
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