Associate Dir, Clinical Data Management Study Lead

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Role Summary

The Assoc Director, 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. Mentor 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 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.

Qualifications

• Required: Bachelor’s degree in mathematics, science or a related field, along with at least 10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred
• Required: Directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment. High degree of creativity, latitude and attention to detail required.
• Required: Knowledge of all applicable regulations including CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills required.
• Required: Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required.
• Preferred: Experience with JMP and SAS.