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Summary: The Clinical Data Coordinator provides basic and some comprehensive data management expertise to data management team to provide efficient, quality data management products that meet customer needs. The position is also expected to undertake team leadership activities under the supervision of the Data Operations Coordinator, Data Team Lead, or Functional Manager.
· The person may serve as a Data Operations Coordinator (DOC) for one protocol with less than 5 operations staff (excludes DE) or a leadership role in a specific area or process on a large study with guidance.
· The person may serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.
· The position calls for conduct of data review.
· To write and resolve data clarifications.
· To lead database audit team
· To develop and test databases and edit specifications
· To understand and comply with core operating procedures and working instructions.
· To perform other duties and directed by the Data Operations Coordinator or Functional Manager.
· To meet objectives as assigned.
· To develop and maintain good communications and interpersonal relationships with the team.
· A graduate degree or Post Graduate degree/diploma (preference in Health Science, Science, or Clinical) with 1 to 3 years of Clinical Data Management experience is preferred.
· Good organizational, communication, leadership and computer skills required.
· Ability to exercise excellent attention to detail required.
· Ability to act independently and with initiative required to resolving problems.
· Medical terminology exposure required.
· Understanding of data management process from study start-up through to database lock
· Knowledge of operating procedures and work instructions and the ability to apply them in practice
· Understand basic financial management concepts
· Able to present information effectively to individuals and small groups
· Able to make independent decisions within scope of authority and considers the impact of decisions on other groups/people.
· Basic understanding of Drug Development Process and its relevance to Data Management
· Excellent interpersonal skills
· Basic understanding of database technologies
· Good spoken and written knowledge of English language with the ability to prepare written communications using correct spelling, grammar and punctuation
· Position requires long periods of keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.