Clinical Data Governance Specialist

1 day ago

Kolkata, West Bengal, India beBeeDataCoordinator Full time ₹ 8,00,000 - ₹ 11,00,000

Job Overview:

The Senior Clinical Data Coordinator position is a key role in our organization, responsible for ensuring the accuracy and completeness of clinical trial data. This involves coordinating with cross-functional teams to design, implement, and maintain databases and data management systems.

  • Data Management: The successful candidate will be responsible for project-specific document tracking and control activities, including CRF reviews and DMTMF/e-filing.
  • Document Preparation: Prepares project-specific documents, including data clarification forms and updates to clinical databases.
  • Training and Support: Conducts project and process-specific training for subordinates and assists in maintenance of documents for audits.
  • QC and Compliance: Performs basic QC functions and ensures SOP compliance in project deliverables.

Key Responsibilities:

  • Initiate project-specific DMTMF/e-filing and review on an ongoing basis.
  • Prepare project-specific documents, including data clarification forms and updates to clinical databases.
  • Coordinate with CDA in User Acceptance Testing (UAT) leading to robust database design.
  • Perform procedure verification as a part of database validation.
  • Conduct manual data listings as needed.
  • Assist in preparation/review of departmental SOPs.
  • Acting as a back-up for Data Manager.
  • Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

Requirements:

  • A strong understanding of clinical trials and data management principles.
  • Excellent communication and interpersonal skills.
  • Able to work independently and collaboratively as part of a team.
  • Familiarity with database design and implementation.
  • Ability to analyze complex data and identify trends.

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