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Job Description :
Sr Clin Data Coord-1513360
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Provide solid core and some comprehensive data management expertise to Data Management 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 DM task (e.g. lead of a task on a megatrial, coder, and database designer for technologies that don’t require extensive programming expertise).
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.
Manage delivery of projects through full data management study life-cycle (with minimal guidance).
With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-of-scope work.
Serve as 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.
Solve 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.
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.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of clinical drug development process
Background in Medical Terminology, Pharmacology, Anatomy, and Physiology
Excellent organizational, communication, and data management skills (detail oriented)
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Bachelor’s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 1 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Primary Location: India
Organization: IND02 – India – CDS/Product Devel
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