Temp Data Manager

Pay Range: $84.90 - $109.38/hr

Remote Role (US Only)

12 Month Contract

The Temp Clinical Data Manager works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM). Works with involved parties to assure that DMM is prepared according to company SOPs and in compliance with Regeneron’s data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron’s SOPs and policies and practices.

In This Role, a Typical Day Might Include:

.  Serves as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.
•  Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron’s SOPs and policies and practices including, not limited to:
o Monitors data clean-up process performed by CROs from study start-up through data archiving.
o Provides data for analysis.
o Coordinates activities including: medical coding; data validation checks and database snapshot.
•  Prepares and distributes project status reports to project team and management.
•  Functions as DM team leader responsible for ensuring databases are validated and ready for 
transfer and/or analyses in accordance with Regeneron SOPs.
•  Creates and maintains 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.
•  Responsible for the initiation and approval of the building, testing and validation of clinical 
databases, subsequent changes in clinical databases and data validation activities.
•  Contributes to upkeep Regeneron DM outsourcing strategies and long-term relationships with 
outsourcing partners with objective of ensuring data quality and efficiencies through data and 
process standardization.
•  Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and 
procedures.

To be considered for this opportunity, you must have the following:

Education
•  Bachelor’s degree in Mathematics, Science or a related field, along with 3 or more years of  clinical data management experience in biotechnology, pharmaceutical or health related industry.

Experience
•  3 – 5 Years Lead experience /  Previous oncology and/or hematology experience a plus

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation