senior manager, clinical data management in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0124228_1533893039
contact
jin quan jonathan soh, randstad
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job description

Job Description

The candidate will work closely with the Clinical Trial team to provide direction and oversight for Clinical Data Management (CDM) deliverables. The candidate will liaise with Contract Research Organizations (CROs) and/or external vendors in all aspects of data management for assigned trial(s).

Job Responsibilities

  • Develop internal CDM guidelines and quality processes to ensure final databases are accurate
  • Set Key Performance Indicators and drive performance within the department
  • Provide oversight and participate in study set-up and initiation procedures such as CRF design, database design, edit check design/review, and DMP (data management plan) review
  • Perform review of clinical trial protocols, with focus on potential CDM issues and cross-study data consistency
  • Oversee all CDM activities performed by CROs, from study start-up, through database lock
  • Ensures the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
  • Manage the incorporation of external datasets and final production of datasets for regulatory submission
  • Perform data validation and quality checks, and initiate corrective and preventive actions as indicated
  • Summarize data to reflect progress of clinical trial(s) and quality of data and sites on periodic and as required
  • Participate in other activities and meetings to support the Clinical Trial Team as needed
  • Represent CDM and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meeting with external vendors

Requirements

  • Bachelor’s or Master’s degree in scientific, biological, statistical, computer science, or related field
  • At least 10 years of clinical trial data management experience
  • Working knowledge of Electronic Data Capture and other trial-associated database systems
  • Proficiency with Microsoft Office (Excel, Word, Outlook, Power Point)
  • Experience in Industry-sponsored Oncology trials an added advantage

Interested and suitable applicants click on the 'Apply Now' button or email Jonathan at jonathan.soh @randstad.com.sg



skills

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qualification

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educational requirements

Bachelor Degree