Manager, Clinical Data Management Study Lead

Regeneron Pharmaceuticals • Armonk, NY

1d

About The Position

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. 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 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, 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 might be for you if: 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 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. 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 working procedures. Responsible for coaching, handling training and leading the direct reports.

Requirements

• Bachelor’s degree in mathematics, Science or a related field, along with at least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry.
• 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.
• Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines.
• Strong communication, leadership and business development skills required.
• Proficient with appropriate EDC applications and Microsoft Office applications.
• Software proficiency with CDMS required.

Nice To Haves

• Previous oncology and/or ophthalmology experience a plus.
• Previous managerial experience is preferred
• Experience with JMP and SAS a plus.

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, 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.
• 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 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.
• 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 working procedures.
• Responsible for coaching, handling training and leading the direct reports.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager