senior manager clinical operations and data management in Singapore

posted
contact
jin quan jonathan soh, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0130866_1551232989
contact
jin quan jonathan soh, randstad
apply now

job description

about the company
A leading biopharmaceutical company specialising in the manufacture of cutting edge oncology drugs

about the job

  • This individual will lead the DM team, roll out appropriate processes and performance metrics to drive DM deliverables. This individual will work closely with the Clinical Trial team to provide direction and oversight for Clinical Data Management (CDM) deliverables. This Individual will liaise with Contract Research Organizations (CROs) and/or external vendors in all aspects of data management for assigned trial(s).
  • Develop internal CDM guidelines and quality processes to ensure final databases are accurate.
  • Set DM objectives to align with company’s needs and directives.
  • 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
  • Provide mentorship and coaching to the team members


about the manager/team

  • This position will be part of a team of 4 reporting to an well-experienced and approachable Associate Director of Clinical Operations and Data Management


skills and experience required

  • Master’s/Bachelor 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






To apply online please use the 'apply' function, alternatively you may contact Jonathan at jonathan.soh@ randstad.com.sg.
(EA: 94C3609/R1656945)






skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree