REMOTE ROLE: Clinical Information Specialist - III (Senior)

PAY $66-75 / hour W2. W2 Candidates only, C2C not possible with this client.

This is a remote role, no expectation of onsite work.

Part time role 10-15 hours per week.

Manager Notes

• The external meetings this individual would need to attend are usually 7 or 8 EST in addition to meetings with Organon team in the mornings US time.
• So ideally would like someone in EST Zone.
• At least 5 years experience leading the design, strategy, and implementation of eCOA platforms in support of study endpoint data.
• No specific eCOA platform is required.
• Participate in study team meetings, provide expert input on eCOA / ePRO design, strategy, reporting, user testing, etc.

Original Job description :

• 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.

Qualifications :

• 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.
• Five or more 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.
30+ days ago