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Career opportunity for Senior Clinical Data Coordinator in Quintiles

 

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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.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Sr Clin Data Coordinator-1403156

Job Description
The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. We are seeking an enthusiastic Rave Technical Designer- Global Data and Safety Monitoring to join our team!

Purpose:
Serve as the EDC System Designer for the Rave build team, and produce accurate and complete specifications documents.


Responsibilities:

  • Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management.
  • Advise and provide justification for design decisions to Technical Lead and at Design Meeting.
  • Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency.
  • This role will eventually (3-6 months after starting) be responsible for providing a draft Edit Check Specification to the DTL.
  • Requires good communication skills and this role will work closely with the Study DTL and Technical Lead and Validation Team Lead
  • Requires a technically logical thinker to resolve questions and issues with the Technical Lead, DTL and VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.

Candidate Profile:


  • Bachelor's degree or 3 year Diploma with a minimum of 3 years experience in a clinical data management role.
  • Candidates must have prior work experience in CRF design experience.
  • Edit Spec writing experience.
  • Knowledge of eCRF Help.
  • Build Time and Events schedule.
  • Excellent communication skills.
  • Strong technical skills.
  • Excellent leadership skills.
  • Candidate must have a thorough knowledge of the clinical trial data management process.
  • Knowledge of Medical Terminology, Pharmacology, Anatomy and Physiology.
  • Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).
  • Excellent organizational, communication, and data management skills (detail oriented).

Additional Information:
Experience: Min. 3 year
Location: Karnataka-Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 1403156
End Date: 22nd May, 2014

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