eCOA Project Manager-Remote

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. Also participates in company business development efforts. This individual may be involved in project management, and may collaborate with staff in other divisions.

What to Expect

• 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.

• Leads a cross functional team comprised of Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, eCOA vendors and others as needed to specify, test, implement and manage study specific eCOA system design.

• 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

• 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 Sponsor’s program

• Involvement in creation of the User Acceptance Testing (UAT) Plan, directing the execution of the test scripts, manage defect tracker leading eventually to System Go-Live.

Education/Qualifications

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).

• Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.

• Fluent in English, both written and verbal

Experience

• Minimum of 3 years of experience providing subject matter expertise, leading study specific implementation, ensuring on time delivery, and remediation of support issues with eCOA system.

• Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions.

• Demonstrated skill in leading teams, by example and mentoring staff.

• Excellent oral and written communication and presentation skills.

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