Clinical Data Manager

OPIS

Full-time Bio & Pharmacology & Health
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Location
batu pahat, johor, Malaysia
Posted
June 14, 2026

Job Description

Overview

As a Senior Clinical Data Manager, you’ll work closely with Sponsors and cross-functional teams to oversee database development, data cleaning, quality control, and database lock activities, while supporting process improvements and mentoring junior team members.

Responsibilities

  • Lead clinical data management activities in compliance with CDISC standards, regulatory requirements, and OPIS SOPs.
  • Design, validate, and maintain eCRFs, clinical databases, and related data management documentation.
  • Perform data cleaning, coding activities, SAE reconciliation, quality checks, and database lock activities.
  • Act as the main point of contact for Sponsors and study teams on data management matters.
  • Track study milestones, manage project deliverables, and proactively identify and escalate risks.
  • Support audits, inspections, process improvements, and the development of data management standards.
  • Mento...