Clinical Data Manager

Clinical Data Manager

Pay Range: $70 - $80/hr

Remote Role (Basking Ridge, NJ)

6 Month Contract

The Temp Clinical Data Manager who will work 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). You will work with involved parties to assure that DMM is prepared according to company SOPs and in compliance with Regeneron’s data standards.

In this Temp Clinical Data Manager role, a typical day might include the following:

• Serve as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.
• Coordinate, lead and perform clinical data management activities for assigned studies in accordance with Regeneron’s SOPs and policies and practices including, not limited to:
• Monitoring data clean-up process performed by CROs from study start-up through data archiving.
• Providing data for analysis.
• Coordinating activities including: medical coding; data validation checks and database snapshot.
• Prepare and distribute project status reports to project team and management.
• Function as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Regeneron SOPs.
• Create and maintain project documentation, including, but not limited to, Data Management Plan, 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.
• Contribute 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.
• Work with study team and coordinates all data management functions. Manage coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.

This job might be for you if:

• You thrive in a collaborative environment.
• You have excellent communication skills and the ability to indirectly influence key partners with clear, concise, and well-formed message tailored to the audience.
• You can manage multiple priorities with a sense of urgency, and effectively manage ambiguity.

To be considered for the Temp Clinical Data Manager role, you must have a Bachelor’s degree in Mathematics, Science or a related field, as well as at least 7 years of clinical data management experience in pharmaceutical, biotechnology or health-related industry.

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