Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
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 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.
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 managers 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.
• 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, managing training and leading the direct reports.
To be considered:
- 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. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred
- Directed and comfortable working in teams with the ability to work and operate independently within a tight deadline 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. Experience with JMP and SAS a plus.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.