Senior Clinical Data Manager — Hybrid, Lead Trials & Standards

MSD Malaysia

Warszawa

Hybrid

PLN 180,000 - 240,000

Full time

11 days ago

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Job summary

MSD Malaysia is seeking a Lead Clinical Data Manager to spearhead end-to-end clinical data management for assigned trials and standards projects. You will design, validate, maintain, and deliver high-quality data management processes and tools in line with SOPs, ICH-GCP, and regulatory requirements, serving as a key contact for study- and standards-level activities and guiding junior staff.

You will coordinate tool specifications (eCRFs, time & events, edit checks, DRPs, data management plans),

Qualifications

Bachelor’s degree in Life Sciences, Computer Science, Health Care, or related discipline with at least 3 years of professional experience in clinical data management.
Associate degree with at least 5 years of professional experience in clinical data management.
High School Diploma or equivalent with at least 8 years of professional experience in clinical data management.

Responsibilities

Lead protocol-level start-up, in-life, and database lock activities for assigned studies.
Design, validate, and maintain data management tool specifications (eCRFs, edit checks, DRPs, DMPs).
Coordinate and/or participate in user acceptance testing (UAT) for data management tools.
Review data integrity, perform reconciliation, and manage query generation, tracking, and resolution.
Coordinate database lock preparation and monitor data flow and issue triage.
Provide support across team roles and act as a trainer for new staff.