Manager, Clinical Data Team

Manager, IVD Clinical Data Team: REMOTE (Preferably located near a major airport in the Eastern half of US)

MUST have:

• IVD clinical trial experience
• Documented IVD management experience (Team lead, manager, other leadership title)

Additional requirements:

• Knowledge of end-to-end data management activities in various IVD clinical studies
• Ability to travel (domestic)10%- 20% required.
• Thorough knowledge of ICH-GCP and STARD guidelines
• Expertise in working with Electronic Data Capture (EDC) systems and clinical data management systems like Medidata Rave and Medrio.
• Bachelor’s Degree with at least 3 years’ relevant work experience as a Manager, Clinical Data Team
• Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g., edit checks), SAE Reconciliation Plan, Data Cleaning Plan, and other DM related documentation.
• Reports to the Senior Manager or Director level professional
• Expertise with the overall data processes such as data review, data clean up, and data quality analysis.
• Experience working as Lead (3+ years) or Senior Data Manager (1+ years) in the IVD space.

Compensation: $130,000 - $140,000 with a 10% bonus

NOTE: Additional informational will not be provided without a phone conversation and resume