Mgr CDM Study Lead

Role Summary

The Manager, Clinical 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 results that meet Regeneron standards and within timelines.

Responsibilities

• 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 results and within the budget. Mentors junior data managers for skills 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, SOPs, and work instructions in compliance with applicable regulations.
• Reviews and approves final archival of project documentation, including but not limited to Data Management Manual, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects. Designs and modifies CRFs.
• Supervises 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 the clinical project team for issue resolution.
• Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with the objective of ensuring data quality and efficiencies through data and process standardization.
• Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
• Establishes goals, expectations and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and procedures. Responsible for coaching, training and leading the direct reports.

Qualifications

• Required: At least 8 years of clinical data management experience in biotech, pharmaceutical or health-related industry.
• Required: Directed and comfortable working in teams with the ability to work and operate independently within a tight timeline environment. High degree of creativity, latitude and attention to detail.
• Required: Knowledge of CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills.
• Required: Proficient with CDMS; experience with EDC applications and Microsoft Office. Software proficiency with CDMS required. JMP and SAS experience a plus.
• Preferred: Previous oncology and/or ophthalmology experience.
• Preferred: Previous managerial experience.

Skills

• Strong communication
• Leadership
• Business development
• Project management
• Vendor and CRO management

Education

• Bachelor’s degree in mathematics, science or related field.