Associate Clinical Data Manager at WEP Clinical ensuring high-quality data management for clinical research programs. Collaborating with cross-functional teams to fulfill sponsor requirements and enhance clinical outcomes.
Responsibilities
Assist in planning and executing data management tasks, ensuring operational efficiency and data accuracy.
Coordinate with clients on study requirements, including study and eCRF design, data review, and data cleaning activities.
Lead data cleaning tasks and delegate appropriately to maintain quality standards and meet deliverable timelines.
Monitor the quality of site-submitted data, ensuring timely, accurate, and compliant database entries.
Ensure all data management practices comply with current GCP guidelines and applicable regulatory standards.
Maintain and actively manage study timelines, identifying risks and addressing milestones proactively to ensure timely completion.
Provide training, guidance, and support to team members and clinical data coordinators on processes, EDC systems, and best practices.
Contribute to the development, testing, and enhancement of data management systems, SOPs, technical tools, and process improvements.
Collaborate with business development to select and manage vendor relationships (e.g., EDC, image upload, IWR/IVR vendors).
Work with external vendors to develop, test, and implement technical solutions that support business needs.
Oversee and support vendor and customer audits, ensuring compliance and efficiency in data management activities.
Participate in business development efforts, including preparing materials, compiling information, and communicating potential challenges in data management processes.
Requirements
Bachelor’s Degree
Strong knowledge of GCP and ICH guidelines
3-5 years of clinical research experience, with a minimum of 1 year of data management experience with a pharmaceutical or medical device company, hospital or CRO
3-5 years of Clinical Trials experience
Excellent communication and presentation skills are essential for success.
Extensive data review and cleaning experience is highly desirable
Clinical data management programming experience with (Medidata and Rave) would be an advantage
Computer literacy and proficiency in Microsoft Office, and experience in data capture systems
Experience with statistics, programming, and field monitoring
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