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Clinical Data Management Specialist

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Job Title: Senior Clinical Data Coordinator

About the Role:

We are seeking a skilled and experienced Clinical Data Coordinator to join our team. As a key member of our department, you will be responsible for ensuring the smooth operation of our clinical data management processes.

  • Key Responsibilities:
  • Project Document Management: Track and control project-specific and departmental documents to ensure timely delivery and compliance with regulatory requirements.
  • Document Review and Preparation: Review CRFs, project-specific documents, and DMTMFs, and prepare project-specific documents as needed.
  • User Acceptance Testing (UAT): Coordinate with CDA in UAT for robust database design and perform procedure verification for database validation.
  • Data Management: Manage Data Clarification Forms and clinical databases for data validity, and conduct manual data listings as needed.
Further Responsibilities:
  • Audit Documentation: Maintain Pre-production and Pre-lock audit documentation to ensure compliance with regulatory requirements.
  • Training and Development: Train subordinates on project/process specific tasks and act as backup for Data Manager.
  • Standard Operating Procedures (SOPs): Review/prepare departmental SOPs and perform basic QC functions for departmental activities.
  • SOP Compliance: Ensure SOP compliance in project deliverables and maintain the highest level of data integrity.
Required Skills and Qualifications:
  • Strong analytical and problem-solving skills;
  • Excellent communication and interpersonal skills;
  • Proven experience in clinical data management;
  • Knowledge of regulatory requirements;
  • Ability to work independently and as part of a team.
Benefits:

We offer a competitive salary and benefits package, including opportunities for career growth and professional development.

Others:

Please submit your resume and cover letter to apply for this exciting opportunity.