Ecoa Manager

Ecoa Manager

Requirements

• 4–6 years of related experience
• Bachelor’s degree in a scientific or technical field (or equivalent experience)
• Expertise in eCOA Systems: Proven track record of managing and supporting eCOA system implementations, including designing, configuring, and validating systems in compliance with industry standards and regulations.
• Clinical Trial Knowledge: In-depth understanding of clinical trial lifecycle, clinical data management, and patient-centric data collection approaches, with the ability to integrate eCOA solutions seamlessly into study protocols
• Project Management: Demonstrated ability to lead cross-functional teams, manage timelines, budgets, and resources effectively, and ensure that eCOA-related projects are delivered on time and within scope.
• Collaboration Skills: Excellent communicator, capable of working with clinical teams, IT departments, and external vendors to implement eCOA solutions that align with project goals and objectives
• Global Experience: Experience managing eCOA solutions in multi-regional and global clinical trials, adapting strategies to different regulatory environments and cultural contexts.

Responsibilities

• Serve as the eCOA Subject Matter Expert, responsible for driving all related deliverables and for overseeing all day-to-day eCOA activities within Study Start-Up and any change management (MSU) support including, but not limited to: Establishes requirements for eCOA solution in conjunction with Study Team Create and maintain eCOA specifications
• Assist in the design and development of the Case Report Forms for any eCOA data collection
• Define and assist in testing Edit Checks and/or Notifications related to eCOA solutions
• Create test cases for the purpose of database validation for eCOA solutions
• Validate study calculations derived from ePRO per Protocol requirements
• In collaboration with Clinical Data Standards Manager, support CDISC compliant mapping of eCOA data
• In collaboration with the Study Team, define and establish eCOA reporting needs
• Provide consultation on the data cleaning strategy for eCOA data
• Create study training materials for use of eCOA solutions (e.g., Site ePRO Guidelines and Participant ePRO Guidelines)
• Review eCOA-related information within study plans (e.g., Data Management Plan)
• Perform database validation for eCOA solution
• Support in providing required translation documentation for regulatory submissions
• Manage changes/updates to eCOA solution throughout the lifetime of assigned projects
• Participate/lead Internal/Sponsor Meetings relating to any eCOA points of discussion, as required, working directly with the assigned Data Management, Database Programming and Project Management Teams
• Ensure approved study documentation pertaining to eCOA configuration is maintained and properly stored in the trial master files
• Act as a point of escalation to any eCOA related issues and queries
• Escalate concepts to the Manager that may impact or benefit the rest of the department or other studies
• Generate and review reports related to eCOA system performance, data quality, user compliance and any issues that arise
• Contribute to the continuous improvement of CDM and the wider organization through information sharing, training, and education
• Promote and be an advocate of DM internally and externally
• Ensure eCOA activities comply with ICH-GCP, FDA, EMA, and other relevant regulatory standards.
• Lead the development, review and implementation of eCOA processes, policies, SOPs/WIs, and associated documents affecting CDM
• Report to MCDM on operational deficiencies, resourcing needs etc. in relation to management of eCOA services
• Lead the development of new concepts, technologies, and products to meet emerging customer needs
• Lead the development of new or improved workflows with internal and external functions, including Alimentiv’s translation vendor(s)
• Collaborate with Clinical Data Standards Manager on the development of eCOA standards
• Provide coaching and support to the cross-functional teams on any eCOA-related topics
• May participate in and/or lead CDM and cross-functional working groups
• Owner and supporter of eCOA-related standard metrics
• Role may support other specialized service offerings, as applicable
• Role may support business development activities in selling eCOA services
• All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.

Preferred Qualifications

• Expertise in eCOA Systems: Proven track record of managing and supporting eCOA system implementations, including designing, configuring, and validating systems in compliance with industry standards and regulations.
• Clinical Trial Knowledge: In-depth understanding of clinical trial lifecycle, clinical data management, and patient-centric data collection approaches, with the ability to integrate eCOA solutions seamlessly into study protocols.
• Project Management: Demonstrated ability to lead cross-functional teams, manage timelines, budgets, and resources effectively, and ensure that eCOA-related projects are delivered on time and within scope.
• Collaboration Skills: Excellent communicator, capable of working with clinical teams, IT departments, and external vendors to implement eCOA solutions that align with project goals and objectives.
• Global Experience: Experience managing eCOA solutions in multi-regional and global clinical trials, adapting strategies to different regulatory environments and cultural contexts.