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Manager, Clinical Data Management

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York, United States of America
Start date
Jul 2, 2021

View more

Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

The 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 extremely detail-oriented
• 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 6 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.

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Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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