eCOA Senior Project Manager

Job Title: eCOA Sr. Project Manager
Duration: 12 Months 
Location: San Francisco, CA

This is expected to be 1 year assignment

Position Summary

This position is responsible for the end-to-end planning, configuration and implementation of eCOA system(s) used in clinical trials. The role includes vendor management and all things scale related (i.e., oversight of scale licensing management, rater training support, requirement specification/screen report reviews, UAT testing, paper process back-up management, monitoring source data review, DCF processing, Blinded Data Analytics (BDA), and POs/invoices with 3rd party vendors.)

Responsibilities

• Serve as subject matter expert for the eCOA set-up and maintenance activities through the lifecycle of the system.
• Provide advice and recommendations to study teams regarding system design alternatives.
• Lead the cross functional study team through document review, changes of scope, providing technical expertise, assessment of risk, oversight of system requirements updates and user acceptance testing.
• Oversee vendors and manage global device provisioning, logistics and returns.
• Manage project budgets and monitor out of scope modifications.
• Conduct data reconciliation reviews according to data management review plans including oversight of query resolution.
• Ensure the correction of errors and discrepancies through the DCF process, document permanent data issues, routinely communicate issues with team members and deliver quality databases for analyses.
• Manage issue escalation and resolution with vendors.
• Develop KPI/ tools to support management and provide updates to team.
• Serve as the point of contact specific to inspection readiness activities between the study team and the COA supplier.
• Support the study team in close-out activities/deactivation of the COA system.
• Develop standardization and process improvements for sponsor oversight of eCOA vendors and data analytics

 

Requirements

• A minimum of a bachelor s degree in clinical, biological, computer or mathematical sciences is required. Advanced degree PMP Certified preferred. Equivalent experience may be accepted.
• A minimum of 10 years pharmaceutical development experience with at least 5 years of project management experience for service providers in electronic clinical outcome assessments (eCOA) (e.g., service providers such as Signant Health, Suvoda, Medidata, CRF Health, Clario, CLIN Ink) an
• 5 years of vendor management experience in digital solutions.
• Background in system design, reviewing requirements and build documentation including digital implementation of eCOA/ Reporting, User Acceptance Testing (UAT), data reconciliation, and query resolution.
• Experience in dermatology (Atopic Dermatitis and Alopecia Areata) preferred.
• Sponsor oversight experience preferred.
• Strong written and verbal communication skills required.

 

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