
Dr. Karthikeyan Gopal B.D.S
Senior Dentist

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About me
Associate Clinical Data Manager at Novotech
Education

Tamil Nadu Dr. M.G.R. Medical University , Chennai
2002 - 2007Bachelor of Dental suregry Dentistry
Indian healthcare BPO, Bangalore
2018 - 2018Advanced Diploma in Clinical Research, Pharmacovigilance and Clinical Data Management
Experience

Private dental clinic
Jun 2008 - Nov 2018Senior DentistAs I was working as senior dentist, I am the one who was in charge for complete control of the Clinic. • Overseeing the 3 junior dentists case handling in the clinic. • Training them to perform minor surgical procedure, specialty treatments like - Root canal, Prosthetics replacement, to use modern equipment for treatments. • Facial trauma cases for dental treatments• Handling Adverse reaction to due to treatments• Managing the financial section of the clinic• Managing the dental materials and Laser device used used in clinic Show less

Novotech
Dec 2018 - nowResponsibilities:1. Attending kick-off meetings for providing inputs in creation of study protocol, 2. Regular Client meetings regarding project timelines from a data management perspective and status of the study progression.3. Reviewing of project feasibility from a data management perspective and providing inputs on budget development for DM activities and scope of work which needs to be performed.4. Participates in project internal team meetings as required. 5. Input into the preparation of RFPs in liaison with BD and the clinical team. 6. Liaison with the project team, Client, and Vendors for preparing and maintaining Data Management Plans, Third party Data Transfer Plans.7. Responsible for all aspects of data management including: • Design and review of database structure, validation rules and consistency checks • Operation of Clinical Data Management Systems• All data cleaning/validation tasks and study Metrics reporting to internal team and Client.• Development of all key Data Management Documents- DMP, DTP (External Data Transfer Plan), eCRF completion guidelines, DMR.• Medical coding activities and internal review of final medical coding listings including other CDMs studies.• Performing Study soft lock as well hard locking of Database• Post lock activities like – data export for Stats and database Decommissioning.• Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders • Liaison with external service providers on Data Management projects as appropriate • Database post-production changes due to study protocol amendments8. Study Financials:• Review of the Study DM task budgets• Perform accurate study financial projections• Working on Monthly project financials for creating invoice for the DM tasks performed.9. Mentoring and training a new joiner for role of Data Manager and Medical coder Show less
Associate Clinical Data Manager
Nov 2021 - nowSenior Clinical Data Associate
Aug 2020 - Oct 2021Clinical Data Associate I
Dec 2018 - Jul 2020
Licenses & Certifications

Coding with MedDRA
Maintenance and Support Services Organization (MSSO)Mar 2019
MedDRA: Safety Data Analysis and SMQs
Maintenance and Support Services Organization (MSSO)Mar 2019
Certified Professional Coder (CPC)
American Academy of Professional CodersSept 2018
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