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Clinical Data Management Associate Specialist

msd · ARG - Buenos Aires - Munro

Nuevo
Hybrid Mid 🇬🇧 English
EDC DDC eCOA Data validation Query management User Acceptance Testing (UAT)

Descripcion del puesto

About the role

Merck is hiring an Associate Specialist, Clinical Data Management in Buenos Aires. Working under the direction of senior staff, the Associate Specialist carries out core data management activities for assigned trials in line with protocols, SOPs and regulatory requirements, supporting data entry, validation, reconciliation, query management and documentation so that data quality and audit readiness are maintained.

Key responsibilities

  • Carry out clinical data management activities for assigned studies according to SOPs, ICH-GCP, timelines, quality targets and protocol requirements, under routine supervision.
  • Support clinical data review, including reconciliation, logical consistency checks and remediation of data from multiple sources.
  • Manage queries raised to clinical sites and service providers, resolving them in collaboration with Site Monitoring and Medical Monitoring.
  • Review, validate and reconcile data across sources such as digital health technologies, eCOAs, central laboratories, imaging, vendor portals and the clinical database (EDC/DDC).
  • Identify and escalate data quality issues such as recurring queries, inconsistent or missing data and late vendor transfers.
  • Support specimen and specialty data workflows, including tracking and reconciliation of samples, images and other patient specimens.
  • Verify protocol-aligned laboratory data setup and confirm that laboratories use protocol-appropriate normal ranges.
  • Contribute to study documentation such as the Data Management Plan, Data Validation Plan, edit check specifications and eCRF completion guidelines, keeping records complete and traceable.
  • Assist with User Acceptance Testing (UAT) and change control, and support additional projects and continuous improvement initiatives.

Required profile

  • Non-degree: minimum 2 years of experience in data management, clinical trial operations or a related field.
  • Or an Associate's degree (preferred in Nursing, Pharmacy, Life Sciences, Allied Health, Data / Information Technology or Medical Technology) with at least 1 year of experience in data management or clinical trial operations.
  • Or a Bachelor's degree (preferred in the same fields) with experience in data management or clinical trial operations preferred.
  • Or an Advanced Degree (Master's or Doctorate) in a preferred field.

Required skills

  • Basic knowledge of data collection, analysis, trending and summarization in a research or medical setting.
  • Basic understanding of relational database concepts (tables, keys, data types).
  • Preferred: experience in data management, medical research and/or database design or development.

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Source : ats:workday

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msd

ARG - Buenos Aires - Munro