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
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post : Sr. Clinical Data Coordinator
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
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Candidate Profile
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 + years of experience.
Requirement:
1) A minimum of 5 years clinical data management or other relevant experience
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
Additional Information:
Location: Chennai/Trivandrum
Education: Bachelor’s degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Data Coordinator
End Date: 21st September, 2017
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