Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Sr. Clinical Data Coordinator-1420095
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.
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Qualifications
• A Bachelors/ Masters degree (preferably in Health Sciences, Science or Clinical)
• Other relevant degree with 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.
• 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
Additional Information:
Experience: 1-2 year
Location: Karnataka- Bangalore
Last Date: 31st March, 2015
Job Id: 1420095
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