Ecoa Manager

Company	Alimentiv
Location	San Diego, CA, USA
Salary	$86000 – $140000
Type	Full-Time
Degrees	Bachelor’s
Experience Level	Mid Level, Senior

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.