eCOA Project Manager
eCOA Project Manager
The eCOA Project Manager is accountable for the client's study specific eCOA system implementation, ongoing conduct support, closeout and decommission. Provides subject matter expertise, leads study specific implementation, ensures on time delivery, and remediation of support issues. Also participates in company business development efforts. This individual may be involved in project management, and may collaborate with staff in other divisions .
- Oversee outsourced eCOA systems that are implemented within a trial
- Proactive follow-up with Sponsor and Third Party Vendor to ensure comprehensive understanding of study design and technology design (Involve a kick-off meeting with various stakeholders) with a view to providing quality deliverables.
- Leads a cross functional team comprised of Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, eCOA vendors and others as needed to specify, test, implement and manage study specific eCOA system design.
- Serve as subject matter expert on best practices for all aspects of eCOA
Act as a central knowledge repository regarding eCOA experiences and shares lessons learned across teams
- Provide expert input on all eCOA related specification requirements
Review User Requirement Specifications and any other eCOA related specifications to ensure sound implementations and configurations that will meet study specific and the Sponsor's program
- Involvement in creation of the User Acceptance Testing (UAT) Plan, directing the execution of the test scripts, manage defect tracker leading eventually to System Go-Live.
- Same responsibilities, post production release. Deliverables include but not limited to:
- Coordinating the review and approval of Sponsor and Third Party Vendor generated documents (Business Requirement Documents, Configuration specs, Project Management Plan, UAT Plan, Study Manuals and Guides)
- Tracking of documentation
- Maintenance of the TMF for Sponsor related documentation
- Adherence to Clinical Planning timelines for System release and any subsequent change controls / amendments and risk assessments
- Representing as eCOA SME for the Sponsor on Clinical Study Team and Design meetings
- Respond to and solve technical oriented problems as appropriate
- Coordinating with all stakeholders during the maintenance phase and provide update to Sponsor teams via regular meetings with Third Party Vendor PM
- Assist Sponsor team members with data transfers, EDC Integrations, Data Clarification / Change Forms
- Coordinate and assist Sponsor teams during close out phase with decommissioning, document archival and eTMF reconciliation.
Bachelor of Science in Engineering or other relevant field, generally in the life sciences (HEOR, public health, biostatistics, etc.) with focus in software, clinical studies.
- 1-3 years of experience as eCOA Project Manager
- Interest in health care, clinical studies, pharma/biotech industry and experience with data management and/or ePRO
- Experience managingcomplex eCOA solution implementation
- Proficiency in converting business function needs and reference documents into complete and comprehensive systems specifications
- Proficiency in converting complex technical and business requirements into an understandable test plan and test cases
- Experience with clinical systems, such as CTMS, ePRO, IRT, EDC or other related technology in the pharmaceutical/biotechnology industry
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