Job Description: Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting.
Requirements
- Ensure the data collected meets the requirements of the study objective and company quality standards.
- Assist in the development and implementation of strategic vision for data management (DM) group.
- Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding
- Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc.
- Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
- Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Mentor clinical team members by resolving problems and providing DM guidance.
- Manage multiple and varied tasks, prioritize workload with attention to detail.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Drive the spirit of âONE Teamâ across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
- Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- May manage, coach, and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
Benefits
- medical
- dental
- vision
- retirement savings plans
- short- and long-term incentives
