As a Medical Study Operations Associate you will be responsible to lead operational activities related to Data Migration of study documents from Legacy systems to a New Study Management Solution. This will include solutions Externally Sponsored Research (Investigator-Initiated Studies and Research Collaborations) and Managed Access Programs (Single Patient and Expanded Access).

A typical day may include the following:

• Lead Data Migration and coordinate activities to meet timelines and deliverables.
• Work collaboratively with team members across team to ensure data migration activities are on track according to timelines, issues are identified and raised appropriately, and deliverables are clearly communicated.
• Systems Management: Learn to use existing systems which contribute to cross-functional communication, planning and transparency, including but not limited to Study Management System, MS Teams and SharePoint.
• Essential Document Maintenance of appropriate (Global) documentation in support of Externally Sponsored Research and Managed Access Programs.
• Review document repositories, work with internal and external collaborators to establish naming conventions and mapping requirements for transfer.
• Responsible for tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities.
• Process: Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.

This may be for you if:

• Have coordinated data migration projects
• Want to have an impact on patient lives.
• Can work effectively in a rapid-response environment.
• Enjoy collaborating with different partners (clinical, pre-clinical, commercial, external customers)
• Want to make a difference in developing processes and systems.

To be considered this position requires a minimum BA/BS degree in a related field. Active working experience and/or courses pertaining to clinical research and/or Medical Affairs areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information.