Provides expertise on the Clinical Data Management activities.
Key Responsibilities:
• Plan and lead Data Management activities for multiple (multi-site and multi-cohort) projects for both clinical trials and PMS (Post Marketing Surveillance) with accountability for successful completion to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations
• Create complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide recommendations to
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improve data status during study conduct
• Define and specify clinically complex data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining,
performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected and ensure appropriate validation documentation.
• Provide guidance and recommendations to clinical team regarding data error evaluation, collection issues, and TFLs.
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related field , 5 years' experience in Clinical Data Management (CDM) .
Experience in clinical research and post market surveillance project is required.
Additional Skills:
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite (including advanced Excel) and EDC (Electronic Data Capture) systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• English skills to communicate with global team
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of Clinical Data Management processes and/or systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project managers and Clinical Affairs team
• Consult in project setting within specific sections of Clinical Data Management area
• Provides Clinical Data Management leadership to outsourcing partners on a task level
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control