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Senior Data Management Specialist

2 weeks ago

Jaipur, Rajasthan, India beBeeClinical Full time ₹ 50,00,000 - ₹ 80,00,000

Job Overview:

  • We are seeking a highly skilled Senior Clinical Data Coordinator to fill this key role.
Key Responsibilities:
  • Document Management: The successful candidate will be responsible for project-specific and departmental document tracking, control activities and ensuring data accuracy throughout the process.
  • CRF Reviews: Reviews CRF (as per protocol) and project-specific documents to ensure compliance and consistency.
  • Data Governance: Responsible for initiating project-specific DMTMF (Data Management Trial Master File) and e-filing, reviewing it on an ongoing basis and maintaining up-to-date records.
  • Project Documentation: Responsible for preparing project-specific documents, including reports and updates as required.
  • Client Support: Handling requests/issues by the client and team in coordination with Project Managers.
  • Database Development: Coordinates with CDA in User Acceptance Testing (UAT) leading to robust database design and implementation.
  • Procedure Validation: Performs procedure validation as a part of database validation to ensure accuracy and efficiency.
  • Data Clarification Forms: Responsible for creating, reviewing, processing and tracking of Data Clarification Forms and updating clinical databases for ensuring data validity as per the protocol.
  • Manual Data Listings: Conducts manual data listings as needed to ensure accurate data reporting.
  • Document Maintenance: Assist in maintenance of the documents for Pre-production and Pre-lock audits to ensure compliance and consistency.
  • Training and Development: Conducts project and process specific training for subordinates to enhance their skills and knowledge.
  • Backup Support: Acting as a back-up for Data Manager to ensure seamless operations in their absence.
  • SOP Compliance: Assists in preparation/ review of departmental SOPs to ensure adherence to regulatory requirements.
  • Quality Control: Conducts basic QC functions for departmental activities to ensure quality and integrity.
  • Ongoing Support: Ensures SOP compliance in project deliverables and contributes to the overall success of the team.
  • Policies and Procedures: Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

Please note that this job description is not exhaustive and may change based on the requirements of the role or company.