eCOA Project Manager
Remote based within Canada
Are you a passionate clinical research professional ready to lead the charge in groundbreaking trials? Join Fortrea as a eCOA Project Manager and drive clinical excellence!
About the Role
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.
Key Responsibilities
- 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.
- Involvement from Creation of the Request for Proposal up to Creation of the User Acceptance Testing (UAT) Plan, directing the execution of the test scripts, manage defect tracker leading eventually to System Go-Live.
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Same responsibilities, postproduction 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.
Qualifications
Minimum Requirements:
- 2-5 years of experience in project management of development of eCOA and DCT systems and validation.
- BA/BS and 2 years of experience OR Associate degree and 5 years of experience
- 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, IVRS, Inform or other related technology in the pharmaceutical/biotechnology industry
Work Environment & Benefits
- Opportunities for professional growth and development.
- Competitive compensation and benefits package.
Be the leader who transforms clinical trials into lifesaving solutions. Apply today to join Fortrea and make a global impact!
Learn more about our EEO & Accommodations request here.