Director, Data Management Operations

Location
Basking Ridge, NJ, United States
Posted
Feb 01, 2019
Ref
14834BR
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary:
Set global vision, strategy and direction for the Data Management Operations function. Accountable to ensure all Data Management Operations subfunction Leads support assigned trials at a consistently high standard with respect to cost, quality and timelines. Lead the Data Management Operations group and assign Subfunction Heads to facilitate open communication within BDM, between Global Development departments, and serve as a cross-functional conduit to provide information about DM Operations. Accountable to ensure quality targets and timelines are met for all clinical trials supported by DM Operations subfunctions.

Job Duties:
Champion the development of DM Operations subfunction SOPs, technical manuals, and other subfunction documentation.

• Sponsor the development, coordination, and maintenance of training courses for the assigned DM Operations subfunction process activities and technologies used.

• Lead the development and reporting of metrics for assigned DM Operations subfunctions, working with the DM Head (sponsor), CPMO Analytics team, and technical teams.

• Develop for assigned DM Operations subfunction(s) planning and resource management tools, and performance metrics to achieve excellence in operations.

• Drive the continuous improvement of assigned DM Operations subfunctions with DM Process Improvement and Knowledge Management, and the CPMO Processes and Procedures group support.

• Contribute to the strategy of the DM Operations subfunctions as a DMLT member.

• Facilitate open communication within DM groups (CDM, Database And Global Library Development, and DM Data Integration, Inspection Readiness and CAPA Management, and DM Process Improvement and Knowledge Management), serving as a conduit to provide information about DM Operations.

• Ensure quality targets and timelines are met for all clinical trials supported by the assigned DM Operations subfunctions.
Participates in FSP selection and performance management to control expenditure.

Adheres to procedures surrounding retention of data, records, and information for clinical studies.

May provide Subject Matter Expert Support for select topics assigned.

Requirements:

Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data integration into EDC experience and 10 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
May be required to manage up to 6+ direct reports; oversee managers.
o 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.
o 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' line management or global project team leadership experience. Proficient with appropriate EDC applications, prevalent vendor data systems of labs, eCOA/ePRO, and local lab information. Additionally, Microsoft Office applications. Software proficiency with CDMS required.
May manage up to 6+ direct reports and in a matrix environment. Strong coaching and training skills - team player. May report to Senior Director 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.
LMR, Director Data Management, Data Management Operations, Clinical Data Managemen, #LI-LR1