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Senior Clinical Data Specialist

2 weeks ago

Tiruchi, Tamil Nadu, India beBeeClinicalData Full time ₹ 40,00,000 - ₹ 60,00,000

Job Overview:

We are seeking an experienced Clinical Data Coordinator to join our organization. The successful candidate will be responsible for managing clinical data activities, ensuring accuracy and integrity, and collaborating with cross-functional teams.

Key Responsibilities:
  • Document Management: Responsible for project-specific and departmental document tracking and control activities.
  • CRF Reviews: Conducts CRF (as per protocol) and project-specific document reviews to ensure compliance.
  • Data Management: Initiates project-specific DMTMF (Data Management Trial Master File) and e-filing, reviewing it on an ongoing basis.
  • Document Preparation: Prepares project-specific documents as required.
  • Client and Team Coordination: Handles client and team requests/issues in coordination with the Project Manager.
  • Database Design and Validation: Collaborates with CDA in User Acceptance Testing (UAT) leading to robust database design and performs procedure verification as a part of database validation.
  • Data Clarification and Tracking: Creates, reviews, processes, and tracks Data Clarification Forms and updates clinical databases for ensuring data validity as per the protocol.
  • Manual Data Listings: Conducts manual data listings as needed.
  • Document Maintenance: Assists in maintenance of documents for Pre-production and Pre-lock audits.
  • Training and Support: Provides project and process specific training for subordinates and assists in preparation/review of departmental SOPs.
  • QC Functions: Conducts basic QC functions for departmental activities and ensures SOP compliance in project deliverables.
  • Compliance and Governance: Ensures compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
Requirements:
  • Educational Background: Bachelor's degree in a related field such as healthcare or life sciences.
  • Experience: 2+ years of experience in clinical data management.
  • Skills: Strong understanding of clinical data management principles and practices, excellent communication and organizational skills, proficiency in MS Office and relevant software applications.
Benefits:

Our organization offers a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.

About Us:

We are a dynamic organization committed to delivering high-quality services to our clients. Our team is dedicated to excellence and customer satisfaction.