Objective
Intuitive, Creative, Analytical Over-thinker: seeking a position as an organizational, management, or Clinical Data Analyst.
Qualifications:
- Bachular Degree in Science and Professional Diploma in Clinical Data Management.
- Four years experience in Clinical Data management, Clinical data project handling and team handling.
- Outstanding communication skills, both verbal and written, and an inane ability to think strategically and problem-solve effectively.
Technical Skills:
- Various Clinical Data management databases: EDC systems: InForm, Rave and Data Labs. Paper Systems: Oracle Clinical and Data Fax
- Microsoft Office, Including Excel, Word, PowerPoint, and Outlook.
Experience:
Clinical Data Analyst - II aug 2008 – present.
PAREXEL INTERNATIONAL
- Project team leadership experience
- EDC and Paper based Study experience
- Hands on experience with tools: EDC tools: INFORM, Rave and Data Labs Paper based tools: Oracle Clinical (OC) and Data Fax
- Drive the activities like eCRFs freezing and eCRFs locking to achieve the final database Lock.
- Discrepancy Management experience
- Query Management experience
- Ability to work independently, under pressure demonstrating initiative and flexibility
- Data base User acceptance test experience
- Edit checks User acceptance test experience
- Serious Adverse Event Reconciliation experience
- ECG Reconciliation and Lab Reconciliation experience
- Creating Study documents like CCI experience
- DVS Writing experience,
- Writing UAT test data experience
- Knowledge in data base structures (forms, visits, variables)
- Knowledge in data review and can request listings needed to perform data review
- Assumes overall responsibility for the successful execution of the projects assigned to me.
- Maintains study documentation training records and other important documents with wet ink signature as well as soft copy documents of the projects assigned to me.
- Perform formal quality check of team members to ensure data base quality.
- Strong organizational and attention to detail skills.
- Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP.
- Good interpersonal and communication skills and ability to operate effectively in an international environment.
- Help create, modify, and publish operational querying reports pursuant to internal and sponsor reporting needs.
- Ability to Identify, troubleshoot, and resolve simple-to-complex data related concerns and provides a thorough explanation of the issue and the intended action plan to resolve such matters.
Clinical Data Analyst – I Sep 2007 – Aug 2008.
ICON CLINICAL RESEARCH
- Lead a small project team.
- Paper based Study experience
- Hands on experience with Paper based tools: Oracle Clinical (OC) and Data Fax
- DB lock experience
- Discrepancy Management experience
- Query Management experience
- Ability to work independently, under pressure demonstrating initiative and flexibility
- ECG Reconciliation and Lab Reconciliation experience
- Knowledge in data base structures (forms, visits, variables)
- Assumes overall responsibility for the successful execution of the projects assigned to me.
- Maintains study documentation training records and other important documents with wet ink signature as well as soft copy documents of the projects assigned to me.
- Strong organizational and attention to detail skills
- Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP
- Good interpersonal and communication skills and ability to operate effectively in an international environment
- Ability to Identify, troubleshoot, and resolve simple-to-complex data related concerns and provides a thorough explanation of the issue and the intended action plan to resolve such matters.
CLINICAL DATA COORDINATOR Nov 2005 - Sep 2007.
Dr. Reddy’s Laboratories Ltd.
- Worked as a team member and performed complete data management activities from setup to DB lock and QC after programming.
- Paper based studies on customized database.
- DB lock experience
- Discrepancy Management experience.
- ECG Reconciliation and Lab Reconciliation experience.
- Good interpersonal and communication skills.
- Test data writing experience,
- User Acceptance Test of customized database,
- Lead Data entry team and responsible for completion of data entry with standard quality, addressing issues in Data compare.
- Database lock experience.
- QC of listings, Tables and Figures after Biostatics programming.
- Trail Master File maintenance
Education:
- Bachelor Degree in Science (Chemistry, Physics, Geology)
From Andhra University Vishakhapatnam, April, 1998.
- Professional Diploma in Clinical Data Management
From Catalyst Clinical Services, Delhi. May, 2008.
- PG Diploma in Computer Applications
From Andhra University Vishakhapatnam Apr 1997.
