eCOA Project Manager

eCOA Project Manager (TEMP)

This position is responsible for the eCOA Project Management including (but not limited to) the following examples of functional tasks:

• The role includes all things scale related (i.e., scale licensing management, POs/invoices with 3rd party vendors, paper process back-up management and oversight, monitoring oversight of source data review, DCFs for paper back-up process conducted by the CRO, vendor management oversight of eCOA including oversight of Blinded Data Analytics (BDA).
• Provide advice and recommendations to study teams regarding system design alternatives.
• Provide leadership and subject matter expertise for the completion of set-up activities through the lifecycle of the system.
• Lead the cross functional study team through changes of Product, providing technical expertise, assessment of risk, oversight of system requirements updates and user acceptance testing.
• Conduct data reconciliation reviews according to data management review plans including oversight management of query resolution.
• 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/deactivation of the COA system .

Requirements for eCOA PM 15+ years industry experience, indication experience in dermatology (Atopic Dermatitis preferred) and data analytics experience in addition to the following:

• 3-5 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).
• 3-5 years of vendor management experience in digital solutions. Background in system design and build including digital implementation, data reconciliation, and query resolution.
• Demonstrated history of leadership roles and subject matter expertise for the completion of set-up activities related to eCOAs.
• Demonstrated experience leading cross functional study teams through changes of Product, providing technical expertise, assessment of risk, oversight of system requirements, updates, and user acceptance testing.
• Issue escalation management by leading the resolution of the issues escalated by the study teams as well as cross-team specific issues
• Strong written and verbal communication skills, and slide presentation creation.

Bachelors degree, advanced degree + PMP Certified preferred.