drjobs Associate Clinical Data Manager

Associate Clinical Data Manager

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1 Vacancy
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Job Location drjobs

Albany - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:
  • Assist in the development testing and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).
  • Support database setup activities including edit check specifications and user acceptance testing (UAT).
  • Review incoming clinical data for completeness consistency and accuracy.
  • Generate track and resolve data queries in collaboration with clinical sites.
  • Maintain study documentation and data management files.
  • Participate in cross-functional study team meetings and data review discussions.
  • Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g. labs central imaging).
  • Ensure data management activities follow SOPs study protocols and regulatory standards (e.g. ICH-GCP CDISC).
Requirements:
  • Bachelors degree in a life science health science pharmacy public health or related field.
  • Strong attention to detail organizational and time management skills.
  • Proficiency with Microsoft Office Suite (Excel Word PowerPoint).
  • Effective written and verbal communication skills.
  • Ability to learn and apply technical systems and software (EDC CTMS etc.).
  • Familiarity with clinical trial processes and Good Clinical Practice (GCP).
  • Experience with EDC systems (e.g. Medidata Rave Veeva Vault Medio) a plus.

Employment Type

Full Time

Company Industry

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