Senior Clinical Data Specialist

3 days ago

Surat, Gujarat, India beBeeClinical Full time ₹ 8,00,000 - ₹ 12,00,000

Job Title: Senior Clinical Data Coordinator

About the Role

We are seeking an experienced and skilled Senior Clinical Data Coordinator to join our team. As a key member of our organization, you will be responsible for project-specific and departmental document tracking and control activities, ensuring seamless collaboration with the team and clients.

Key Responsibilities
  • Document Review and Tracking: Conduct thorough reviews of CRF (as per protocol) and project-specific documents to ensure accuracy and compliance.
  • Data Management: Coordinate project-specific DMTMF (Data Management Trial Master File) and e-filing, reviewing it on an ongoing basis.
  • Project Documentation: Prepare project-specific documents, handling requests/issues by the client and team in coordination with the Project Manager.
  • Database Design: Collaborate with CDA in User Acceptance Testing (UAT), leading to robust database design and validation.
  • Procedure Verification: Perform procedure verification as a part of database validation.
  • Data Clarification Forms: Create, review, process, and track Data Clarification Forms, updating clinical databases for ensuring data validity as per the protocol.
  • Manual Data Listings: Conduct manual data listings as needed.
  • Training and Development: Provide project and process-specific training for subordinates.
  • Back-up Support: Act as a back-up for the Data Manager.
  • SOP Compliance: Ensure SOP compliance in project deliverables.
  • Regulatory Compliance: Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies etc. for conducting delegated activities.
Requirements

To be successful in this role, you will require strong organizational skills, attention to detail, and effective communication to ensure successful project outcomes. The ideal candidate will have experience in clinical data management, data entry, and document tracking.

Benefits

This is a rewarding opportunity to work with a dynamic team, develop your skills and expertise, and contribute to the success of our organization.

About Us

We offer a supportive and collaborative work environment, opportunities for professional growth and development, and competitive compensation and benefits packages.

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