Senior Mgr Data Management
The Senior Manager, Data Management will engage in providing direction on assigned clinical data management projects across multiple therapeutic areas. The ideal candidate will have the ability to assure accurate planning and execution for data management results that proactively meet Regeneron standards within (and optimally ahead of) timelines. We need someone who can work collaboratively to drive positive outcomes in the development of SOPs, Working Practices and other essential components of running a world-class data program. We are at the forefront of seamlessly integrating science and technology, and this opportunity will play a key role in weaving solid data practices into our approach.
A typical day might include the following:
•Engaging key therapeutic area leaders to discuss comprehensive project planning and issue resolution
•Mentoring and coaching junior data managers for development and advancement
•Leading the initiation and approval of the building and validation of clinical databases, subsequent changes in clinical databases and data validation activities
•Drives the development of outsourcing strategies and long-term relationships with outsourcing partners. Our objective is to ensure data quality and efficiencies through data and process standardization.
•Creating dynamic relationships with contract research organizations (CROs) and vendors to deliver on partnered projects meeting all data management specs.
This role may be for you if:
•You are passionate about data management and energized by coordinating efforts to deliver phenomenal project documentation including Data Management Manuals, CRF Completion Guidelines and validation specifications
•You have the innate ability to identify areas for process improvement and quickly initiate action plans to resolve them
•You are someone who leads by example and inspires staff with follow-through and commitment
To be considered for this opportunity, a minimum of a Bachelor’s degree in Mathematics, Science or a related field is required. To aid in your successful transition onto our team we prefer someone to have least 8 years of clinical data management experience in biotech, pharmaceutical or a health-related industry. We also know that having previous oncology and/or ophthalmology experience will assist you greatly, so experience in either field is also preferred. We are looking for an individual who can operate independently while effectively leading and motivating the efforts of a diverse team, so previous managerial experience is greatly preferred. To be effective in this role you must have comprehensive knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines. Proficiency with appropriate EDC applications and CDMS is required. Experience with JMP and SAS is preferred.
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.