The Manager/Senior Manager, Clinical Data Systems (eCOA, eConsent) is accountable for clinical business systems operations; ensuring that systems are designed and implemented with appropriate controls and successfully adopted. In partnership with the AD, Clinical Data Systems, the Manager/Senior Manager, Clinical Data Systems will assist and/or function as business system owner for key clinical trial systems with a focus on eCOA and eConsent technologies and vendors. The responsibilities for this position may also extend to other technologies used for hybrid and decentralized trials (DCT), such as telehealth, site/patient portals, sensors, and wearables.
- Function as business system owner for eCOA and eConsent technologies, and other DCT technologies as assigned.
- Help to facilitate vendor assessment and selection activities.
- Drive system implementation on trials with direction from AD, Clinical Data Systems and strong partnerships with stakeholders across Clinical Development.
- Lead development of, and maintenance of, system standards, standard business procedures, best practices and associated training.
- Drive standardization of documents, templates, license management, trainings and processes with preferred technology vendors. Support SOP/standard creation of services with cross-functional collaboration and knowledge of country-specific processes and procedures while adhering to industry best practices, GDPR, GCP, ICH and international regulations. Serving as Business System Administrator ensures compliance with ICH E6 risk management and data integrity requirements as applicable to eCOA/eConsent systems.
- Support Author instrument management, license management and translations management with the vendor and CTWG (Clinical Trial Working Group).
- Drive study User Acceptance Testing in partnership with study teams. Develops study-level User Acceptance Test (UAT) Scripts and supports UAT execution with study teams for eCOA/eConsent system implementations.
- Can act as primary vendor contact for oversight of system operations, changes and JOC ( Joint Operating Committee) / QBR (Quarterly Business Review) governance, as applicable; Provide issue identification and effective service resolutions and innovation to Agios/vendor JOC/QBR members in order to meet corporate and department/cross-functional CTWG goals and strategic vision.
- Monitor performance and quality metrics and compliance with agreed SLA with vendors.
- Provide subject matter expertise and participate, as necessary, in vendor selection for new vendors and/or technology solutions that best align to Agios needs in order to enhance the patient and provider end user experience when participating in an Agios clinical trial.
- Function as SME advising internal teams and vendors on best practices in eCOA, eConsent design to ensure regulatory compliance, cost and operational efficiency, data integrity and user (site/patient) experience.
- Engage with IT/QA to support appropriate risk-based validation activities as applicable. Evaluates system releases against business requirements, performs risk assessments and aligns with IT and QA and creates the validation deliverable documents based on level of validation required for each system release as applicable.
- Bachelor’s Degree with 5+ years of clinical operations and/or clinical data management experience in pharmaceutical/biotechnology industry with 3+ years relevant work experience with a focus on eClinical technologies such as eCOA and eConsent.
- Experience with eCOA implementation on global studies at a sponsor, CRO or vendor is required; experience with eConsent implementation and other technologies that facilitate decentralized protocols is preferred.
- Strong project management skills, and ability to effectively lead and collaborate with various business functions.
- Knowledge of regulatory guidelines and global regulations, including GCP/ICH, FDA/EMA/CHMP, 21 CFR Part 11, GxP validation requirements.
- High attention to detail including proven ability to manage multiple, competing priorities.
- Demonstrated ability to influence change.
- Excellent written and oral communication skills.
- Flexibility and cross functional collaboration.
- Must be able to perform under tight timeframes and execute problem solving skills.