Clinical Data Manager

Overview

• Provide data management support for clinical trial programs in a fast-paced environment.
• Collaborate with cross-functional teams to ensure data management deliverables align with program strategies.
• Draft and review essential data management documents, including annotated CRFs and data management plans.
• Perform user acceptance testing for electronic data capture systems and ensure compliance with industry standards.
• Monitor vendor performance through key metrics and escalate issues as necessary.
• Develop and implement data transfer agreements with external vendors.
• Support the creation and review of eCRF designs and edit check specifications.
• Ensure proactive communication and escalation of risks during cross-functional team meetings.

Key Responsibilities & Duties

• Collaborate with CDM Leads to manage operational activities for assigned programs.
• Maintain program-level timelines for data management deliverables, addressing timeline issues proactively.
• Draft and review eCRF designs and edit check specifications, ensuring cross-functional alignment.
• Perform sponsor EDC user acceptance testing and ensure compliance with standards.
• Develop data transfer agreements and interact with external data vendors effectively.
• Create and implement key data and metrics reports for program monitoring.
• Provide accurate study status updates and escalate data management issues during team meetings.
• Ensure adherence to CDISC/CDASH standards and industry best practices.

Job Requirements

• Bachelor of Science degree in a relevant field.
• Minimum of 8 years of clinical trial data management experience in pharma/biotech.
• Proficiency in electronic data capture systems, particularly Medidata Rave.
• In-depth knowledge of CDISC/CDASH standards and data management best practices.
• Strong ability to manage competing priorities and adapt to changing environments.
• Excellent verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Demonstrated ability to work independently and meet project timelines effectively.