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Wednesday, 27 November 2013

Quintiles hiring Senior Clinical Data Coordinator "D"

Job Title : Sr. Clinical Data Coordinator
 
Job Description : 
  • The Sr. Clinical Data Coordinator provides comprehensive data management expertise to Data Management.
  • The position also requires to provide efficient, quality data management products that meet customer needs. Provide leadership either in the role of the Data Operations Coordinator (DOC), or in a leadership role in a specific Department task.
  • Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. (See Responsibilities Document for role description)
  • Manage delivery of projects through full data management study life-cycle (with minimal guidance)
  • Manage project timelines (with guidance from DTL or Manager)
  • Management of quality (with guidance from DTL or Manager)
  • Determining resource needs (with guidance from DTL or Manager)
  • Identify Out of Scope Work
  • Serve as back-up for Data Operations Coordinator or Data Team Lead (with guidance)
  • Perform comprehensive data management tasks including data review, writing and resolving data clarifications
  • Perform database designer activities for technologies not requiring extensive programming
  • Perform comprehensive quality control procedures
  • Independently bring project solutions to the CDM team.
  • Solves issues through using the global issue escalation/communication plan.
  • Consult with Standards Group for process issues; communicate ideas for process improvement
  • Assist in developing and implementing new technology.
  • Understand and comply with core operating procedures and working instructions.
  • Perform other duties as directed by the Data Operations Coordinator, Group Manager.
  • Meet objectives as assigned.
  • Develop and maintain good communications and working relationships with CDM team.
  • Interact with CDM team members to negotiate timelines and responsibilities.
Educational Qualifications : A Bachelors/ Masters degree (preferably in Health Sciences, Science or Clinical)  or Other relevant degree 
Experience : Minimum 1-2 years of relevant work experience (clinical trials experience in function similar to DM) and a total work experience of at least 4 years.
Required Skill Set :
  • A background in Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
  • A thorough understanding of clinical drug development process.
  • The position expects excellent organizational, communication, and data management skills.
  • The incumbent must be detail oriented.
  • Position requires long periods of keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • 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 prepare written communications using correct spelling, grammar and punctuation
  • 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
  • Able to motivate and lead teams to reach defined objectives.
  • Effective team management skills including conflict resolution, delegation, and change management.
  • Excellent interpersonal skills are required.
  • Comprehensive understanding of database technologies.
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