Director of Clinical Data Management Operations
Director of Clinical Data Management Operations
Executive Staff Recruiters / ESR Healthcare
New York, NY
See who Executive Staff Recruiters / ESR Healthcare has hired for this role
Experienced Clinical Data Management Professional
Location: Remote
Contract: 6 months with possible renewal
Summary
Seeking an experienced Manager in Clinical Data Management with over 12 years of experience. The ideal candidate must have at least 4+ years of direct line management experience, overseeing 3-4 direct reports.
Responsibilities
Location: Remote
Contract: 6 months with possible renewal
Summary
Seeking an experienced Manager in Clinical Data Management with over 12 years of experience. The ideal candidate must have at least 4+ years of direct line management experience, overseeing 3-4 direct reports.
Responsibilities
- Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations (CROs).
- Plan, perform, and oversee the development of specifications for eCRFs/CRF, edit checks, and electronic data handling.
- Conduct scheduled cross-functional data reviews, identify issues, and ensure resolution tracking.
- Participate in the innovation and implementation of new technologies to enhance data management processes.
- Ensure compliance with quality control procedures for data management activities.
- Write and oversee the revision of Standard Operating Procedures (SOPs) and training guidelines for data management.
- Manage and monitor timelines, ensuring resource availability to meet project deadlines.
- Identify and address inconsistencies and inefficiencies in data management processes.
- Assist in proposal and budget preparation for new projects and manage budgets for ongoing projects.
- Direct and manage team members in daily activities, including training, resource allocation, and performance reviews.
- Minimum 12 years of data management experience or a relevant degree with 6-8 years of experience.
- At least 4 years of experience in the Pharmaceutical/Biotechnology industry or CRO environment.
- 6 years of experience supervising Clinical Data Managers and/or team activities.
- Strong proficiency in programming languages like SQL or SAS (desirable).
- Familiarity with data collection tools, Electronic Data Capture (EDC) systems, and related processes.
- Excellent communication skills and the ability to work collaboratively in a multi-disciplinary environment.
- Thorough understanding of regulatory guidelines such as FDA, EMA, ICH, and GCPs related to data handling in clinical development programs.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Business Development and Sales -
Industries
Hospitals and Health Care
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