Senior Clinical Data Specialist

20 hours ago

Tiruppur, Tamil Nadu, India beBeeClinical Full time ₹ 9,00,000 - ₹ 12,00,000

**Job Description:** As a Senior Clinical Data Coordinator, you will play a vital role in managing project-specific and departmental document tracking and control activities.

  • We are seeking someone to review CRF (as per protocol) and project-specific documents, and initiate project-specific DMTMF (Data Management Trial Master File) and e-filing on an ongoing basis.
  • The ideal candidate will be responsible for preparing project-specific documents, handling requests/issues by the client and team, and coordinating with Project Managers.
  • You will also coordinate with Compliance and Data Assurance teams in User Acceptance Testing (UAT), leading to robust database design, perform procedure verification as part of database validation, and create, review, process, and track Data Clarification Forms and update clinical databases for ensuring data validity as per the protocol.
  • An added responsibility will be conducting manual data listings as needed, assisting in maintenance of documents for Pre-production and Pre-lock audits, conducting project and process specific training for subordinates, acting as a backup for Data Manager, and assisting in preparation/review of departmental Standard Operating Procedures.
  • In this role, you will conduct basic Quality Control functions for departmental activities, ensure SOP compliance in project deliverables, and ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies etc. for conducting delegated activities.
Required Skills and Qualifications:

To excel in this position, you must possess strong organizational skills, excellent communication skills, attention to detail, ability to meet deadlines, and willingness to learn.

  • A Bachelor's degree in Life Sciences or related field is required.
  • At least 5 years of experience in Clinical Data Coordination or related field is preferred.
Benefits:

This role offers a competitive salary, comprehensive benefits package, opportunities for professional growth and development, and a dynamic work environment.

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