Clinical Information Specialist II
Our client – global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines – is seeking a Clinical Information Specialist to join their team.
3 month contract, ~10-12 hrs per week.
- Electronic Clinical Outcome Assessment (eCOA) Solutions Lead
- Responsible for collaborating with internal and external stakeholders to ensure that the software solution captures the necessary data points for data extraction, visualization, and real-time integration, implementing optimal eCOA processes, and building and improving relationships with eCOA/ePRO providers.
- Regularly meets with internal and external teams to discuss open and emerging business issues related to eCOA/ePRO projects and systems, makes recommendations for improvements, and leads on their implementation.
- Provide expert input, ensuring that clinical protocols are appropriately mapped to solutions efficiently, accurately and within project scope.
- Identifies, develops, implements, and reviews effectiveness of current and new eCOA processes, including for new services, in collaboration with others.
- Perform and support the UAT of the eCOA/ePRO configurations with necessary documentation.
- Collaborates in the investigation of study issues found beyond the start-up phase of the study, especially the CAPA process with cross-functional teams.
- Reviews and analyzes current metrics to identify trends and suggest process improvements.
- Four-year college/university degree in computer science, engineering, life science, or healthcare related field with at least 5 years of experience working with clinical trials or in pharmaceutical industry.
- Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models.
- 5+ years demonstrated experience leading and implementing eCOA projects across multiple platforms. (Experience in women health is a plus)
- Advanced computing skills, including experience with TRADOS or other translation management tools (CAT, or Computer Aided Translation tools) and eCOA vendor working files (e.g., JSON, XML,)
- Knowledge of regulatory standards/guidance for eCOA/ePRO
- Demonstrated experience leading teams in a matrix working environment across projects.