Senior Manager, eCOA Management

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Senior Manager, eCOA (Electronic Clinical Outcome Assessment) Management

Division: Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM)

Functional Area Description

Global Data Management (GDM) is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.

Position Summary

The Senior Manager, eCOA Management role is essential to the study-level operationalization of the eCOA capability for BMS clinical trials, directly contributing to the BMS R&D pipeline. This role reports to the Associate Director, eCOA Management within GDM and is a full-time, office-based position with flexibility to work from home up to 50% of the time.

Position Responsibilities

·       Provide leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements. Handle complex and high-priority studies.

·       Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.

·       Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.

·       Review and coordinate study-level eCOA process documents with study team members.

·       Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.

·       Resolve eCOA issues during study conduct in collaboration with study team members and vendors.

·       Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.

·       Manage work assignments to ensure timely delivery.

·       Identify and resolve issues that may negatively impact the operationalization of eCOA tools, using collaborative strategies, and escalate issues to leadership when necessary.

·       Follow procedural documents and participate in reviewing and updating them to reflect industry standards and regulatory requirements.

·       Train and mentor newer team members on key activities and processes.

·       Actively participate in and/or lead continuous improvement activities.

·       Support preparations and follow-up actions related to Health Authority inspections and internal audits.

·       Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS, with the ability to think st