Job Description

Title: Clinical Data Manager (Lead)
Location: Remote - must currently reside in the US
6 month renewable contract
W2 only - we cannot work with any other agency 

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:

1. Monitors data clean-up process performed by CROs from study start-up through data archiving.
   
   
2. Provides data for analysis.
   
   
3. 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

Ref: #568-Clinical

Job Tags

Contract work, Remote job,

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