Senior Manager, Clinical Data Management

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following:

• Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
• Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality deliverables and within the budget. Mentor junior data mangers for skill set advancement. If required, leads and performs clinical data management tasks for studies.
• Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP's and work instructions in compliance with applicable regulations.
• Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
This role may be for you if you have experience:
• Supervising DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Coordinates with clinical project team for issue resolution.
• Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
• Ensuring adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
• Establishing goals, expectations, and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, managing training and leading the direct reports.
  
  Bachelor Degree in Mathematics, Science or a related field
• At least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry, managing and coordinating data management related projects is required.
• Minimum 3 years of direct people management experience.
• Previous oncology and/or ophthalmology experience a plus.
• Previous managerial experience is preferred.