ECOA Senior Project Manager

Job Description

Job 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.)

Duties and 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 Product, 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 Product 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).
• 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.
• Strong written and verbal communication skills required.

Preferrences:

• Experience in dermatology (Atopic Dermatitis and Alopecia Areata) preferred.
• Sponsor oversight experience preferred.