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Sr. Clinical Data Coordinator

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About the role

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“At ICON, it's our People that set us Apart”
Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.
We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Job Title                           : Sr. Clinical Data Coordinator
Reporting to                  : Clinical Data Management Group Leader/Manager- Data Management
Type of Employment : Full Time
Location                          : Chennai/Trivandrum
 
Job Overview:
To perform data management activities along with providing training for less experienced CDCs in accordance with Good Clinical Practices and all applicable procedures, guidelines, laws and regulations within specific timeline and quality standards.

Key Responsibilities & Duties:

The specific job duties of a Senior Clinical Data Co-ordinator  may include but are not limited to:
  • Expertise in data management process
  • Act as a single point of contact (internal expert) for specific processing task(s) on a project
  • Responsible for completeness, timely delivery and quality of clinical data
  • Lead and coordinate other team members within the department on assigned studies
  • Mentor project team members and be a subject matter expert when needed
  • Manage project timelines, quality issues and justify out-of-scope.
 
 
Demonstrates full competence when conducting the following tasks
  • Development of database build specifications
  • Development of data validation specifications
  • Test data creation & UAT
  • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
  • Assist with the validation of edit check programs.
  • Data validation and cleaning
  • Study status tracking
  • Review of data listings
  • Conduct SAE & third party data reconciliations
  • Maintaining Clinical Study Documents and archiving as appropriate
  • Represent Data Management at internal / external meetings as appropriate.
  • Perform early and final database QC activities
  • Database lock activities
Academic or Trade qualifications:
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 + years of clinical data management experience.
Requirement    :
  1. A minimum of  5  years in clinical data management 
  2. Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clinical, OCRDC)
  3. Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
  4.  Strong client relationship management skills, and the aptitude to develop this further
Benefit Working with ICON:
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 
PROCESS
 
Technical and competency selection:
When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.
The evaluation will look at your technical skills and your competencies – for example, delivering excellence. Can you give an example when you’ve delivered that in your work environment, for both internal and external customers?
Interview
After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.
Offer
If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.
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