What are the responsibilities and job description for the Senior Clinical Data Manager position at America Zenith?
Principal Clinical Data Manager
Location : Waltham, MA (Onsite)
Company : eteraflex connects
Key Responsibilities
- Data Management Leadership :
- Serve as the lead data manager for assigned studies, guiding data management activities from study initiation to database lock. This role requires active involvement in data review, query management, and quality assurance to ensure complete, accurate, and compliant data.
- Stakeholder Collaboration and Communication :
- Act as the primary data management point of contact across multiple studies, collaborating closely with internal study teams, external labs, CROs, and vendors. Effectively communicate data requirements, timelines, and quality standards to ensure smooth project execution and alignment across all stakeholders.
- EDC and eCRF Development :
- Lead the development and deployment of eCRFs and database specifications tailored to each protocol, utilizing systems such as Veeva, Medidata Rave, and Oracle Clinical. Participate in User Acceptance Testing (UAT) to ensure that all EDC functionalities align with protocol requirements and are ready for high-quality data capture.
- Data Management Planning :
- Develop comprehensive Data Management Plans (DMP) that include CRF annotations, database specifications, edit check standards, and data handling processes. This plan will serve as the foundational document guiding data management practices and ensuring compliance and consistency throughout the study lifecycle.
- Vendor and Quality Oversight :
- Oversee and manage external vendors and CROs to maintain accountability and compliance with data management timelines, quality standards, and regulatory requirements. Validate external data transfers and perform regular audits to ensure data accuracy and audit-readiness.
- Performance Metrics and Process Improvement :
- Establish and monitor key data management performance metrics, tracking efficiencies in data cleaning, query resolution, and database locking processes. Lead initiatives for continuous improvement, optimizing workflows to enhance data processing accuracy and speed.
- Training and Mentorship :
- Act as a mentor and subject matter expert for data management team members, providing guidance on best practices, protocol-specific requirements, and regulatory standards. Conduct training sessions to ensure consistent adherence to SOPs and the highest quality of data practices.
- Project Coordination and Prioritization :
- Oversee data management timelines, proactively identifying and addressing risks to ensure on-time database locks. Coordinate across departments to manage priorities, drive efficiencies, and maintain focus on high-impact deliverables.
Qualifications
Education
