Senior Manager, Data Management Reports Development
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.
Leads the Reports Development group within the Clinical Data Management Operations group. Establishes and maintains the standard library of data cleaning reports to support both outsourced and in-house studies.
- Establish and champion the development of DM cleaning reports for outsourced and in-house processes, technical manuals, and other communications.
- Collaborates with neighboring functions to meet data review and cleaning needs for all studies
- Sponsor the development, coordination, and maintenance of training courses for the DM cleaning process activities and technologies used.
- Lead the development and reporting of metrics for the Data Management use of standard data cleaning reports, working with the DM Head (sponsor), CPMO Analytics team, and technical teams.
- Set the strategy for data cleaning activities for Data Management.
- Identify continuous improvement initiatives for DM cleaning activities with DM Process Improvement and Knowledge Management, and the CPMO Processes and Procedures group support.
- Facilitate open communication within DM groups (with TA Heads) to ensure all study-specific data cleaning needs are met.
- Participates in FSP selection and performance management to control expenditure of resources for reports development activities
- Adheres to procedures surrounding retention of data, records, and information for clinical studies
- May provide Subject Matter Expert Support for select topics assigned
Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data management reports development experience and 10 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology experience a plus.
- Self directed and comfortable working in cross-functional teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required.
- Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required.
At least 5 years of graduated, direct experience defining, configuring, and using data review tools (JReview, Medidata CSA, Medidata Rave Listings, and/or Spotfire) to develop data cleaning reports for the Data Management department. Familiar with appropriate EDC applications, prevalent vendor data systems of labs, eCOA/ePRO, and local lab information. Additionally, Microsoft Office applications.
May manage up to 6+ individuals as direct reports and in a matrix environment. Strong coaching and training skills – team player. May report to Director, DM Operations or above.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.