Senior Manager, Clinical Data Solutions (eCOA)

Company: Labcorp
Location: Durham
Posted on: October 12, 2021

Job Description:

Job Overview:

Senior Manager, Clinical Data Solutions(eCOA)

Responsibility for delivering UAT tasks within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data.

• Provide coordination of virtual global UAT teams as needed to complete UAT projects.
• Maintains and utilizes a strong knowledge of SOPS and validation/UAT work procedures/standards in relation to the tasks.
• Manage UAT documentation packages including Test Scripts, Testing Results, Traceability Matrix, etc.
• Review Scope of work for the assigned project.
• Support Resource management tracking.
• Leads UAT teams as assigned
• Manage project and coordination of eCOA UAT activities
• Support Clinical Project Management Lead in all activities related to eCOA development, and eCOA integrations into external and internal systems
• Oversee internal project team on project and verification plan, programming, testing, localization, and implementation of project specifications
• Manage key-account relationships, to ensure all eCOA projects delivered meet the same requirements
• Develop and maintain eCOA processes and trainings for improved performance across the team
• Provides support to the leadership team

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.

Experience:

• Minimum 10 - 12 years of relevant work experience to include Validation activities or equivalent experience.
• Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions.
• Demonstrated skill in leading big teams, by example and mentoring staff.
• Excellent oral and written communication and presentation skills.
• Knowledge of overall clinical trial process and data management, CDISC.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Demonstrated ability to work in a team environment.
• Demonstrated ability to handle multiple competing priorities.
• Proven managerial and interpersonal skills.

Keywords: Labcorp, Durham , Senior Manager, Clinical Data Solutions (eCOA), Other , Durham, North Carolina