Senior Clinical Data Coordinator

IQVIA

Bangalore Rural, Mumbai

Hybrid

INR 1,200,000 - 1,800,000

Full time

8 days ago
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Job summary

IQVIA seeks a Clinical Data Manager with strong CDM background to oversee end-to-end CDM activities for clinical studies. The role requires hands-on Medidata Rave EDC experience, UAT, and database lock involvement, plus CDISC standards and data cleaning expertise.

You will coordinate with cross-functional teams in a global setting and adapt to rotational shifts and flexible location. Applicants should have 4.5+ years of CDM experience and at least 5 years in CDM overall, with excellent

Qualifications

  • Minimum 5 years of relevant experience in end-to-end Clinical Data Management (CDM).
  • Hands-on experience with Medidata Rave EDC.
  • Strong experience across the complete clinical trial lifecycle, including Study Start-Up, Study Conduct, Study Close-Out.
  • Expertise in data management activities from User Acceptance Testing (UAT) through Database Lock.
  • Willingness to work in shift-based environments as per business requirements.
  • Good understanding of CDISC standards, data review, query management, and data cleaning processes.

Responsibilities

  • Manage and oversee end-to-end CDM activities for clinical studies.
  • Participate in study start-up activities, including CRF review, UAT, and database validation.
  • Perform ongoing data review, discrepancy management, and data cleaning throughout study conduct.
  • Coordinate with cross-functional teams, including Clinical Operations, Biostatistics, Programming, and Data Management stakeholders.
  • Ensure data quality, compliance, and adherence to project timelines.
  • Support database lock activities and study close-out deliverables.
  • Identify process improvement opportunities and contribute to best practices within Data Management.

Skills

CDM processes
Medidata Rave EDC
UAT & DB Lock
CDISC standards
Regulatory knowledge
Stakeholder management

Job description

Experience Required: Minimum 4.5+ Years of Relevant Clinical Data Management Experience

Key Requirements:

Minimum 5 years of relevant experience in end-to-end Clinical Data Management (CDM).

Hands-on experience with Medidata Rave EDC.

Strong experience across the complete clinical trial lifecycle, including:

Study Start-Up

Study Conduct

Study Close-Out

Expertise in clinical data management activities from User Acceptance Testing (UAT) through Database Lock.

Willingness to work in shift-based environments as per business requirements.

Good understanding of CDISC standards, data review, query management, and data cleaning processes.

Key Responsibilities:

Manage and oversee end-to-end CDM activities for clinical studies.

Participate in study start-up activities, including CRF review, UAT, and database validation.

Perform ongoing data review, discrepancy management, and data cleaning throughout study conduct.

Coordinate with cross-functional teams, including Clinical Operations, Biostatistics, Programming, and Data Management stakeholders.

Ensure data quality, compliance, and adherence to project timelines.

Support database lock activities and study close-out deliverables.

Identify process improvement opportunities and contribute to best practices within Data Management.

Preferred Skills:

Strong knowledge of clinical trial processes and regulatory requirements.

Excellent communication and stakeholder management skills.

Ability to work independently in a fast-paced and global environment.

Experience with sponsor-facing projects is an added advantage.

Location: Flexible
Shift: Flexible/Willing to work in rotational shifts as required.
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