Description
Job Details:
- The electronic Clinical Outcomes Assessments (eCOA) Technical Specialist will work with a cross functional team of Clinical representatives to support the design, implementation and maintenance of outsourced eCOA systems to support a clinical trial
- The individual within this role will provide technical oversight to ensure that the study specific eCOA systems adheres to the study protocol, industry regulations/best practices as well as company policies, procedures and guidelines
- Accountable for quality delivery and competencies within the eCOA service area. Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
- Assist in the design and development of study specific technical documents
- Support the internal team in managing project related timelines and associated activities
- Partner with data management (DM) to define the requirements for data transfers
- Work with external resources to manage the creation and execution of user acceptance tests
- Identify and track study-related technical issues to resolution
- Provide a supportive framework for continuous process and quality improvements
Skills:
- BS or RN Degree
- Experience in pharmaceutical or biotech clinical data management (CDM)
- Experience in managing study level projects
containers and "drug product"