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Senior Clinical Data Manager – Clinical Trials

msd · POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center)

New
Senior 🇬🇧 English
User Acceptance Testing Data integrity review Query management

Job description

About the role

Under the direction of management, the Senior Clinical Data Manager is responsible for end‑to‑end data management activities across clinical trials, including tool development, validation, data integrity review, query management and database lock execution, in line with SOPs and ICH‑GCP guidelines.

Key responsibilities

  • Develop, validate and maintain data management tools and systems such as eCRFs, edit checks and data review plans.
  • Perform data integrity reviews, reconcile data, manage queries and support in‑life and database lock activities.
  • Coordinate User Acceptance Testing (UAT) and ensure successful implementation of clinical databases.
  • Communicate site‑level issues with the clinical team and track global study status, metrics and issue resolution.
  • Mentor and coordinate other CDMs and SCDMs on the protocol to ensure compliance with SOPs and data management plans.
  • Participate in cross‑functional process improvement projects and contribute to SOP and training material updates.

Required profile

  • Minimum 3 years of experience in clinical data management, preferably in a Senior Clinical Data Manager or Clinical Data Manager role.
  • Experience handling larger, complex or high‑priority protocols in early and late stage development.

Required skills

  • eCRF design and implementation.
  • Development of edit checks and data validation rules.
  • User Acceptance Testing (UAT) coordination.
  • Data integrity review, query management and database lock execution.

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Published 1 dzień temu

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msd

POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center)