Bibin Thomas
Summary
Seeking to join a highly reputed and professional clinical research work environment to apply best data management practices and experiences. Eager to contribute to team success and gain excellent career advancement opportunities.
Overview
13
13
years of professional experience
Work History
Sr. Clinical Database Designer
IQVIA RDS (India) Private Limited
11.2022 - Current
- Attend Kick Off Meeting and regular project meetings until Study Go Live
- Review Project Plan and escalate issues (if any) to all stakeholders
- Interprets the study protocol
- Design and update the eCRF
- Create and update Edit Specification Document
- Provide project status updates on database designing activities to Data Team Lead/Lead Programmers
- Co-ordinate with internal/external Customers on a regular basis and establish strong Communications with them
- Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
- Implement proactive quality management plans across multiple projects/programmes
- Track service performance and provide leadership to identify root cause of issues and implement remedial actions
- Continuously look for opportunities to improve the process; work with team to develop and implement plan to re-organize and drive change across multiple projects/programme (with minimal support)
- Ensure timely follow-up and resolution of compliance issues
- Serve as Subject Matter Expert (SME) for Database designing group
- Train and mentor Database designing Team Members
- Provide end to end Project Management for Database designing activities in the team, e.g
- Proactive and accurate resource planning, planning for deliverables, identifying risks (if any) and escalate such risks to the Manager
- Conduct Quality Reviews as applicable
- Review the QIP for appropriate budget allocation and communicate if any out of scope activities are noted
- Review individual project financial performance and communicate issues to the appropriate stakeholders
- Ensure adherence to study budgets
- Supervise implementation of new technology
- Serve as primary point of contact for Internal Customers on Database designing deliverables
- Provide justification for and perform direct negotiations with Internal Customers, e.g., timelines, financial, process, resources
- Develop and maintain strong Customer relationships
Senior CDC (Senior Clinical Data Coordinator)
Icon Clinical Research India Pvt Ltd
07.2021 - 11.2022
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
- Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures
- Assist study lead in development of eCRF, Specification of DM listings/external data reconciliations, validation of DM listings/external data reconciliations and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
- Independently and accurately prepare database test documentation and test data entry screens (UAT)
- Perform validation of edit check programs
- Accurately perform external data reconciliation (Lab, ECG, MRI etc) in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports (database change control forms) as requested
- Assume study lead role when applicable
- Perform Quality Reviews and appropriately address all issues
- Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Independently and accurately generate data queries to resolve data discrepancies
- Appropriately address responses to data queries and accurately update the clinical data as necessary
- Identify and accurately resolve all workflow or clinical data discrepant issues
- Assist with the development, review and the update of relevant Data Management Study Specific Procedures
- Accurately perform Serious Adverse Event (SAE) reconciliation in accordance with all applicable procedures
- Accurately perform external data reconciliation in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports as requested
- Assume study lead role when applicable
- Represent Data Management at internal / external meetings as appropriate
- Effectively mentor less experienced staff
- This may include assisting and guiding new personnel during their initial training period
- Responsible for supporting clinical project teams in managing information flow and data collection in accordance with appropriate regulatory and departmental guidelines
Assoc. Clinical Data Manager/Technical Designer
IQVIA RDS (India) Private Limited
04.2019 - 07.2021
- Interprets the study protocol
- Design and update the eCRF
- Create and update Edit Specification Document
- Attend the Pre-Design Meeting, Online Screen Review Meeting
- Attend and present comments at the Internal Design Review Meeting
- May lead Online Screen Review Meeting
- Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document
- Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan
- Escalate potential quality issues
- Identify areas for process improvements on an ongoing basis
- Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes
Senior CDC (Senior Clinical Data Coordinator)
Icon Clinical Research India Pvt Ltd
10.2011 - 04.2019
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
- Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures
- Assist study lead in development of eCRF, Specification of DM listings/external data reconciliations, validation of DM listings/external data reconciliations and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
- Independently and accurately prepare database test documentation and test data entry screens (UAT)
- Perform validation of edit check programs
- Accurately perform external data reconciliation (Lab, ECG, MRI etc) in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports (database change control forms) as requested
- Assume study lead role when applicable
- Perform Quality Reviews and appropriately address all issues
- Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings
- Independently and accurately generate data queries to resolve data discrepancies
- Appropriately address responses to data queries and accurately update the clinical data as necessary
- Identify and accurately resolve all workflow or clinical data discrepant issues
- Assist with the development, review and the update of relevant Data Management Study Specific Procedures
- Accurately perform Serious Adverse Event (SAE) reconciliation in accordance with all applicable procedures
- Accurately perform external data reconciliation in accordance with all applicable procedures
- Generate, review for accuracy and distribute status reports as requested
- Assume study lead role when applicable
- Represent Data Management at internal / external meetings as appropriate
- Effectively mentor less experienced staff
- This may include assisting and guiding new personnel during their initial training period
- Responsible for supporting clinical project teams in managing information flow and data collection in accordance with appropriate regulatory and departmental guidelines
Education
Diploma - Clinical Research Management (DCRM)
Clinovex - Clinical Research Solutions
12-2010
B.Tech - Biotechnology
St. Michael College Of Engg & Tech
04-2010
12th -
St. Mary's H.S.S.
04-2006
10th -
M.T.S.H.S.S
04-2004
Skills
- Highly encouraging and motivating temperament
- Highly professional approach towards the assigned job
- Self-driven, able to prioritize and implement changes smoothly
- An innovative team player and effective troubleshooter possessing interpersonal, coordination, team building and leadership skills
Profile at a Glance
- A top performing professional with 13 year's of experience (From03Oct2011 - till date), utilizing multi-tasking ability to meet organizational objectives.
- More than 4 years of working experience as a Clinical Database Designer RAVE (Architect/ALS).
- Good understanding of Clinical Data Management, Clinical Research.
- Knowledge of Phase 1 – Phase 4 of clinical trials.
- Good working experience with RAVE EDC and InForm in Clinical Data Management.
- More than 3 years of experience in writing test scripts, UAT, writing specifications for Listings/ external reconciliations, validation of listings/external data outputs.
- Have finished B.Tech Biotechnology from St. Michael college of Engg. & Tech (Anna University-Chennai), Diploma in Clinical Research Management from Clinovex Clinical Research Solutions, Cochin and Internship in Data Management from Icon clinical research India Pvt Ltd.
Languages Known
English
Malayalam
Hindi
Tamil
Personal Details
Date of Birth:26-Sep-1988
Timeline
Sr. Clinical Database Designer
IQVIA RDS (India) Private Limited
11.2022 - Current
Senior CDC (Senior Clinical Data Coordinator)
Icon Clinical Research India Pvt Ltd
07.2021 - 11.2022
Assoc. Clinical Data Manager/Technical Designer
IQVIA RDS (India) Private Limited
04.2019 - 07.2021
Senior CDC (Senior Clinical Data Coordinator)
Icon Clinical Research India Pvt Ltd
10.2011 - 04.2019
Diploma - Clinical Research Management (DCRM)
Clinovex - Clinical Research Solutions
B.Tech - Biotechnology
St. Michael College Of Engg & Tech
12th -
St. Mary's H.S.S.
10th -
M.T.S.H.S.S
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