R-OPENING AS Sr Clin Data Coord @ Quintiles Transnational - Bangalore

Sr Clin Data Coord
Quintiles Transnational - Bangalore, Karnataka

• 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.

• 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