Join as Sr. Clinical Data Coordinator @ ICON "A"

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:

• 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

Apply here