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.
Requirements
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.
Employment Type: Full-Time
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Business Development and Sales
Industries
Hospitals and Health Care
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