Sr. Clinical Data Manager

Responsibilities

• Create external data transfer agreements, ensuring alignment with company Standards and specifications.
• Manage study start up, conduct, and close out activities for external clinical trials.
• Develop and validate infrastructure for external data to flow into company Clinical data pipelines.
• Validate all 3rd Party Data generated in clinical trials into company Clinical Data pipelines.
• Build and maintain strong working relationships with key stakeholders including Clinical Data Management, Clinical Data Engineering, and other Study Execution Team members.
• Participate in preparing functions for submission readiness and represent CT3 group in formal inspections or audits.
• Represent company in interactions with key external partners as part of the CT3 3rd Party Data Acquisition team.
• Timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in the Trial Master File (TMF).
• Follow and participate in reviewing and updating procedural documents to ensure they reflect industry standards and regulatory requirements, including optimal processes.
• Escalate issues to CT3 leadership as necessary.