Job Description

Role: Clinical Data Management Contractor

Contract Length: 6+ months

Location : US Remote; ET working hours

*PLEASE NO THIRD-PARTY APPLICATIONS*

SUMMARY:

Our client is seeking a Clinical Data Manager to collaborate with internal stakeholders and external vendors to ensure delivery of complete and accurate study data. The role involves database setup and testing, quality oversight, documentation, and vendor coordination, supporting both in-house and outsourced clinical studies.

RESPONSIBILITIES:

• Configure or guide development of study databases to align with protocol requirements, including edit checks and query logic
• Generate reports, listings, and performance metrics to track data quality and vendor progress.
• Perform user testing of electronic data capture (EDC) systems prior to study start-up.
• Draft, review, and maintain essential data management documentation (e.g., data management plans, coding guidelines, transfer specifications, EDC specifications).
• Track study progress and ensure milestones are achieved on schedule.
• Assist with oversight of CRO/vendor deliverables for outsourced studies.
• Ensure compliance with SOPs, GCP, and other relevant standards
• Identify and escalate risks to study timelines or data integrity; partner with study teams to drive solutions.
• Maintain Trial Master File compliance for study-specific data management documents.
• Support ad-hoc data management or study-related tasks as required

EXPERIENCE & QUALIFICATIONS

• 5-8 years of hands-on clinical data management experience and bachelor’s degree
• Experience working for a Sponsor company
• Proficiency with EDC platforms specifically Veeva
• Experience with aspects of Study start-up and user testing of EDC systems prior to study start-up
• Ability to generate reports, listings, and performance metrics
• Perform user testing of electronic data capture (EDC) systems prior to study start-up.
• Strong understanding of CDM practices, GCP, and regulatory requirements.
• Advanced Excel skills (pivot tables, formulas); programming experience (e.g., SAS) is a plus.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage competing priorities in a fast-paced environment.

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