Principal Clinical Data Specialist

21 hours ago

Kottayam, Kerala, India beBeeClinical Full time ₹ 7,00,000 - ₹ 10,00,000

Job Overview

We are seeking a highly skilled Clinical Data Coordinator to join our team. As a Clinical Data Coordinator, you will be responsible for overseeing the collection, organization, and maintenance of clinical data.

Main Responsibilities:

  • Project-specific document tracking and control activities
  • Reviews CRF (as per protocol) and project-specific documents
  • Initiating project-specific DMTMF (Data Management Trial Master File) and e-filing with ongoing reviews
  • Preparing project-specific documents
  • Handling client and team requests/issues in coordination with PM
  • Coordinates with CDA in User Acceptance Testing (UAT) leading to robust database design
  • Performing procedure verification as part of database validation
  • Creating, reviewing, processing, and tracking Data Clarification Forms and updating clinical databases for ensuring data validity as per protocol
  • Conducts manual data listings as needed
  • Maintenance of documents for Pre-production and Pre-lock audits
  • Training subordinates on project and process specifics
  • Back-up for Data Manager
  • Preparation and review of departmental SOPs
  • Basic QC functions for departmental activities
  • Ensuring SOP compliance in project deliverables
  • Ongoing delegated activities with applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies

Requirements:

To succeed as a Clinical Data Coordinator, you should have excellent organizational skills, attention to detail, and strong communication abilities. You should also be proficient in using various software applications and tools relevant to the role.

Benefits:

We offer a competitive salary package, opportunities for professional growth and development, and a collaborative work environment that values innovation and teamwork.

Why Join Us:

As a Clinical Data Coordinator, you will play a vital role in ensuring the accuracy and integrity of clinical data. You will have the opportunity to work with a talented team of professionals who share your passion for delivering high-quality results. Our company culture emphasizes collaboration, continuous learning, and community involvement.

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