ALISTER BOSE
Clinical Data Coordinator
Eden, Parassala, Trivandrum
Summary
- My goal is to apply and expand my skills, knowledge, and experience in data management and project administration in order to bring value and high impact to an organization and the clients and community it serves.
- 13 years and 3 months experience in Clinical Research Industry.
Proficiency in RAVE, Inform and OCRDC. - In CDM, I have performed Start Up, Conduct and Close out activities.
Overview
13
13
years of professional experience
6
6
years of post-secondary education
Work History
Clinical Data Lead
ICON Clinical Research (India) PVT. Ltd
07.2022 - Current
- Oversee the planning, execution, and coordination of data management activities for clinical trials.
- Develop and maintain data management plans and data validation plans.
- Ensure that data collection and database design align with the study protocol and regulatory requirements.
- Perform data quality checks to identify and resolve discrepancies or errors in clinical trial data.
- Ensure data validation processes are carried out accurately and in a timely manner.
- Collaborate with database programmers to design and implement electronic data capture (EDC) systems or other data management tools.
- Implement quality control procedures to maintain data accuracy and consistency.
- Lead a team of clinical data managers and coordinators.
- Provide training and guidance to team members, ensuring adherence to standard operating procedures (SOPs) and best practices.
- Collaborate with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs.
- Communicate data-related issues and findings to internal and external stakeholders.
- Address data-related challenges and issues as they arise during clinical trials.
- Develop and implement solutions to ensure data quality and integrity.
Clinical Data Coordinator
ICON Clinical Research (India) PVT. Ltd
05.2016 - 07.2022
- Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
- 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
- Accurately perform reconciliation/listings in accordance with all applicable procedures
- Effectively mentor less experienced staff
- This may include assisting and guiding new personnel during their initial training period.
- Conduct data review.
- Discrepancy management.
- Perform Reconciliation listings for SAE, Lab, PK, and other study specific listings.
- Perform User Acceptance Testing and collaboratively work with CDMS personnel to see if
any issues found through re‑testing and resolution. - Understand and comply with core operating procedures and working instructions.
- Develop and maintain good communications and working relationships with CDM team.
- Freeze and/or lock eCRF's (as appropriate) within the Electronic Data Capture System.
Project Analyst
ICON Clinical Research (India) PVT. Ltd
05.2013 - 05.2016
- Provide independent, objective project tracking review and financial analysis to maintain and/or improve project profitability
- Responsible for all ICON business activities across all functional areas (clinical, data management, statistics, medical, etc.) for each assigned asset/project
- Complete handover of information (specifications, timeline, resourcing, etc.) from proposals and contracts management at the award stage and assist with the re‑costing process until work order signature
- Working closely with other members of the project team, client, clinical/scientific teams, and/or internal and external clients and vendors as‑needed for successful project execution.
Clinical Data Associate
ICON Clinical Research (India) PVT. Ltd
06.2010 - 04.2013
- Update/correct/review data in the clinical databases based on resolved data queries.
- Create and maintain study files and other appropriate study documentation.
- Listings Review.
- Entering subject CRF’s by study into OC system from OPTICON in line with SSP’s.
- Mentoring and delegation of work.
- Study contact and handling more than 15 projects.
- Ensure sharing and learning across projects.
Trial Master File QC - Indexing CRFs
Education
Master of Science - BioInformatics
05.2007 - 04.2009
Master of Business Administration - Project Management
04.2012 - 03.2013
Bachelor of Science - BioInformatics
05.2004 - 04.2007
Advance Diplomo - Clinical Research
05.2009 - 12.2009
Skills
Rave, Inform, OCRDC
undefinedReferences
Pradeepkumar C
Director, Data Management
ICON Clinical Research
Mobile: 9952092618
Hanas Settu
Manager, Data Management
ICON Clinical Research
Mobile: 9995634971
Declaration
I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts.
Alister Bose S L
Timeline
Clinical Data Lead - ICON Clinical Research (India) PVT. Ltd
07.2022 - Current
Clinical Data Coordinator - ICON Clinical Research (India) PVT. Ltd
05.2016 - 07.2022
Project Analyst - ICON Clinical Research (India) PVT. Ltd
05.2013 - 05.2016
National Institute of Business - Master of Business Administration, Project Management
04.2012 - 03.2013
Clinical Data Associate - ICON Clinical Research (India) PVT. Ltd
06.2010 - 04.2013
Klintelligen Health Care - Advance Diplomo, Clinical Research
05.2009 - 12.2009
CMS College of Science And Commerce - Master of Science, BioInformatics
05.2007 - 04.2009
Noorul Islam College of Arts And Science - Bachelor of Science, BioInformatics
05.2004 - 04.2007
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