The eCOA Project Manager is accountable for supporting clients' study specific eCOA solution 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.
Prepare estimates for ePRO work:
Determine client needs
Participate in discussions about workplan and approach, as needed
Prepare budgets and proposal language to support clinical trial proposals
Lead study specific eCOA Implementation Teams:
Leads a cross functional team comprised of Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, vendors and others as needed to specify, test, implement and manage study specific eCOA systems.
Create and drive eCOA related timelines and deliverables
Conduct internal review meetings of eCOA vendor written user specification requirements and integration specifications
Plan, facilitate and lead eCOA study and design review meetings
Ensure completion and approval of all eCOA related documentation including specifications
Ensures compliance with relevant regulations, i.e, GxPs, ICH E6
Study specific primary point of contact for eCOA vendor
Provide advice and direction to eCOA Implementation Team for utilization of vendor eCOA system:
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
Define and complete initial information documents used for requesting a proposed scope of work from eCOA vendor
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 client's program needs
Supply advice and expertise on any proposed system changes after launch
Deliver expertise to the planning and execution of User Acceptance Testing (UAT):
Review and approve a schedule of testing that reflects the agreed User Requirements Specifications (URS)
Create study specific eCOA Test Plan
Create study specific eCOA test scripts for the Sponsor testing team.
Facilitate UAT by providing support to Sponsor testing team and direction to eCOA Study Implementation Team, ensuring that any issues are discussed with the eCOA vendor, and that a course of action is agreed and documentation is completed appropriately
Ensure necessary data exchange (i.e. integrations or data transfers) between eCOA and other systems
Partners with stakeholders to define instances where data exchange is needed
Collaborates with stakeholders to determine data exchange solution
Oversees initial and periodic testing to ensure transfers are timely, efficient and bug-free
Provide guidance to the client's study team for vendor implementation of site initiated data changes
Facilitate collection of close out deliverables from eCOA vendor
Maintain study specific issue and risk log
Document issues and facilitate investigation into root cause, corrective action and, as applicable, preventative action
Track study specific risks and remediation
Organize materials throughout project and ensures that work papers are properly filed and stored for future access
Accountable for study specific eCOA contract, budget and change orders:
Supports Global eCOA Lead in managing and governing eCOA processes at the client.
Assists with collection and reporting of metrics
Suggests improvement to quality procedures and best practices
Conducts, and create if necessary, eCOA related trainings for the client's members
Fosters collaboration among internal stakeholders including but not limited to Clinical Trial Supplies, eClinical Technology, Global Clinical Operations (Study and Site Management), Biostatistics, Data Management, Clinical Procedural Documents & Standards, Clinical Quality, Regulatory and Outsourcing
Advises manager of project status' and issues as they arise.
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.Experience:
Interest in health care, clinical studies, pharma/biotech industry and experience with data management and/or ePRO
Experience managing complex eCOA solution implementation
Proficiency in converting complex technical and business requirements into an understandable UAT Test Plan and UAT Test Scripts.
Experience with clinical systems such as CTMS, IRT, EDC or other related technology in pharmaceutical/biotechnology industry
Experience with supporting proposals and liaising with vendors and/or clients
Apply on company website