Join as Sr. Clinical Data Coordinator @ ICON
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 in accordance with Good Clinical Practices, ICON SOPs and all applicable procedures, guidelines, laws and regulations within specific timeline and quality standards.
Key Responsibilities & Duties: The specific job duties of a Clinical Data Co-ordinator I may include but are not limited to:
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 in accordance with Good Clinical Practices, ICON SOPs and all applicable procedures, guidelines, laws and regulations within specific timeline and quality standards.
Key Responsibilities & Duties: The specific job duties of a Clinical Data Co-ordinator I 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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