Temp Clinical Outcome Assessment Manager

Location: UK or Ireland

Job Summary and Essential Functions:

The Clinical Outcomes Assessment Manager (COM) is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. Other accountabilities include the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.

This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct leadership versus oversight of eCOA will vary accordingly.

In this role a typical day might include:

• Responsibility & accountability for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
• Responsibility for reviewing and approving project related eCOA study documentation during the Project Lifecycle
• Providing input into protocol development as it relates to clinical outcomes
• Participating in creation of eCOA standards
• Supporting Clinical Study Lead with license acquisition
• Responsibility for eCOA and translation vendor selection
• Leading all aspects of eCOA vendor performance at the clinical trial level, including oversight of critical metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
• Contributing to risk management planning and coordinating resolution & risk mitigation of all eCOA systems related issues and end of study vendor reports
• Being responsible for communication planning, information distribution, performance reporting, and project closure.
• Providing support for problem resolution between eCOA vendors and Regeneron study team
• Supervising financial components related to COA and Innovation for each study
• Collaborating with study team members on medical monitoring plan
• Collaborating with data management on eCOA data specifications, standards, and transfers
• Providing training and mentorship to new staff
• Applying problem solving strategies to issues and maintaining issue tracking documentation supervise progress and ensure timely resolution to critical issues
• Developing strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
• Facilitating communication of clinical innovations in eSource modalities to partners and broader organization
• Supporting strategy for implementation of innovative clinical trial technologies and ground-breaking innovations
• Providing consultation on eCOA modality benefits, risks, costs and process
• Facilitating and chipping in to study level lessons learned
• Recommending and participating in cross-functional and departmental process improvement initiatives
• May require up to 25% travel
• This role may be for you if:
• You have demonstrated knowledge of eCOA systems development processes
• You have the ability to understand and implement the strategic direction and guidance for respective clinical studies
• You have a data driven approach to planning, executing, and problem solving
• You can perform and handle multiple tasks at one time to meet deadlines in a sophisticated environment working
• You are a multifaceted leader who can influence and negotiate at all levels internally and externally
• You have a depth of experience managing external vendors
• You are an effective project manager with cross-functional team leadership and organizational skills

To be considered, you must have a Bachelor's degree strong, proven eCOA or ePRO relevant experience. Knowledge of ICH/GCP and regulatory guidelines is also vital for success in the role. You will also need to have shown technical proficiency in trial management systems and Microsoft Project Server.

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