The eCOA Manager is responsible for the successful deployment and oversight of electronic Clinical Outcome Assessments (eCOA) solutions at Alimentiv, including (but not limited to) electronic Patient Reported Outcome (ePRO) & eConsent collection. This role collaborates with internal teams, Sponsors, and external vendors to ensure eCOA solutions are configured, tested, and maintained to meet study requirements, regulatory requirements, and industry best practices. By providing expert guidance and leadership, the eCOA Manager drives effective deployment strategies, supports risk mitigation, and ensures data integrity throughout the study lifecycle. This role will contribute to process improvement, knowledge sharing, and training initiatives to enhance Alimentiv’s capabilities in delivering high-quality eCOA services.
Project Support (60 to75%)
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 specificationsAssist in the design and development of the Case Report Forms for any eCOA data collectionDefine and assist in testing Edit Checks and/or Notifications related to eCOA solutionsCreate test cases for the purpose of database validation for eCOA solutionsValidate study calculations derived from ePRO per Protocol requirementsIn collaboration with Clinical Data Standards Manager, support CDISC compliant mapping of eCOA dataIn collaboration with the Study Team, define and establish eCOA reporting needsProvide consultation on the data cleaning strategy for eCOA dataCreate 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 solutionSupport in providing required translation documentation for regulatory submissionsManage changes/updates to eCOA solution throughout the lifetime of assigned projectsParticipate/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 TeamsEnsure approved study documentation pertaining to eCOA configuration is maintained and properly stored in the trial master filesAct as a point of escalation to any eCOA related issues and queriesEscalate concepts to the Manager that may impact or benefit the rest of the department or other studiesGenerate and review reports related to eCOA system performance, data quality, user compliance and any issues that arise
Department Support (30 to 35%)
Contribute to the continuous improvement of CDM and the wider organization through information sharing, training, and educationPromote and be an advocate of DM internally and externallyEnsure 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 CDMReport to MCDM on operational deficiencies, resourcing needs etc. in relation to management of eCOA servicesLead the development of new concepts, technologies, and products to meet emerging customer needsLead 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 standardsProvide coaching and support to the cross-functional teams on any eCOA-related topicsMay participate in and/or lead CDM and cross-functional working groupsOwner and supporter of eCOA-related standard metricsRole may support other specialized service offerings, as applicableRole may support business development activities in selling eCOA servicesAll employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.
QUALIFICATIONS
4–6 years of related experienceBachelor’s degree in a scientific or technical field (or equivalent experience)
ADDITIONAL KNOWLEDGE / SKILLS
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 protocolsProject 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 objectivesGlobal Experience: Experience managing eCOA solutions in multi-regional and global clinical trials, adapting strategies to different regulatory environments and cultural contexts.
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. 
