Clinical Data Manager

2 weeks ago

San Fernando, Central Luzon, Philippines Scrubbed Full time
Overview

The Clinical Data Manager (CDM) is responsible for clinical data management operations and activities, such as data review (Query management, data listings review, etc.), including external lab vendor and SAE reconciliations. CDM is also responsible for EDC testing and data cleaning. The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

Responsibilities
  • Support Internal Clinical Data Management Initiatives
  • Complete assigned Data Management Operations/Activities
  • Review CRF/eCRF data for completeness, accuracy, and consistency via system edits and manual data checks (data review listings)
  • Contribute to Project Success by conducting duties per the LDM/Study lead request.
  • Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System (Medidata RAVE, Veeva EDC, etc.)
  • Perform external vendor reconciliations
  • Perform SAE reconciliation
  • Code data per selected coding dictionaries if applicable
  • Participate in User Acceptance Testing (UAT) under the supervision of the Study Lead
  • Assist with data transfers, loading, and integration
  • Complete all required documentation per EDETEK and project requirements
  • Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations
Qualifications
  • A bachelor's degree in life sciences is required.
  • A minimum of 2 years of core clinical data management experience is required.
  • Prior trial responsibility for the entire data management life-cycle is desirable.
  • Prior experience in external data vendor reconciliation and SAE reconciliation is required.
  • Prior experience of EDC UAT is preferred.
  • Ability to communicate effectively in the English language in person, by phone and in writing.
  • Strong attention to detail and accuracy is a must.
  • Excellent organizational skills.
  • Ability to work collaboratively, effectively, and productively in diverse organization structures.
  • Ability to work in a team-oriented, collaborative environment.
  • Ability to work positively within a continually changing environment.
  • Ability to effectively prioritize and execute tasks in a high-pressure environment.
Seniority level
  • Entry level
Employment type
  • Full-time
Job function
  • Research, Analyst, and Information Technology

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