Karthik Srivatsa Chiravuri
Hanumakonda
Summary
Clinical Operations professional with over 16 years of experience in client relationship management and team leadership. Delivered comprehensive support in clinical operations, data processing, and analysis while adhering to protocol and ICH-GCP guidelines. Focused on enhancing organizational objectives through strategic management and innovative IT initiatives.
Overview
16
16
years of professional experience
Work History
eTMF Administrator
Parexel International India Pvt. Ltd
Hyderabad
04.2016 - Current
- Working as "eTMF Administrator" in Admin department with "Admin access" to all studies dealing with tickets raised by users in Vault / P-Med.
- Experienced in eTMF file maintenance process, handling trial related documents and performing first quality check on the documents and moving them into a specified folder/s of the CF location.
- Escalating the quality findings with the document owners and requesting them to make the necessary corrections on a timely manner.
- Follow-up on the escalation that are made earlier and suggesting the document owners on the best practices followed around and on how to avoid the errors at the first instance to make sure that the progression of the project deliverables is smoothly handled, avoiding the roadblocks.
- Creating, maintaining, and terminating user accounts in the EDC database as per the SOPs.
- Created, modified, and deactivated sites on Electronic Data Capture (EDC) system.
- Performing database lock and unlock as per the requirements of the study team.
- Hands on Experience on InForm (4.6, 5.5, 6.0 & above UMT) and Rave/Medidata databases.
- Executed ad hoc requests and tasks based on client and organizational needs.
Site support specialist - Level - II
C3i Support Service-Quintiles Global Operations Centre project
Hyderabad
02.2010 - 04.2016
- Extended support as a Project coordinator for the EDC system DiscoverE / Cerner database.
- Attending Weekly calls with the Project managers and sponsor representatives to update the status of the projects and steps taken to prevent firefighting scenarios.
- Sharing Quality findings with the client / sponsor designee and involvement in the preventive measures discussions to avoid issues that may occur in the future.
- Prepared SOPs and KOs for the specific processes within the database and made sure that the information is available for the team members in their day-to-day activities.
- Co-coordinating with the teams involved with the projects and made sure that all the workload is handled within the timelines Or SLAs.
- Attending Quarterly calls with the Sponsors and the C3I management to predict the workflow and allocation of the resources accordingly.
Clinical Analyst - Level II
C3i Support Service-Quintiles Global Operations Centre project
Hyderabad
02.2010 - 04.2016
- Created, maintained, and terminated user profiles on the Inform database following SOPs.
- Creating and deactivating Sites and associating\dissociating users to the same on Electronic Data Capture (EDC) system.
- Performed study start-ups for new studies, escalating errors to Oracle team for timely corrections.
- Locked and unlocked databases according to study team specifications.
- Performed ad hoc requests and tasks based on client and organizational needs.
- Handling Calls with the end users and resolving their concerns over the call to provide immediate resolution. Escalating issue to Oracle team through incident management tickets (Phase forward), follow-up on the pending issues as per the SOPs.
- Assisted new hires on the floor, conducted daily quality checks, handled escalations, performed SLA checks, and managed workload of Level I team members during shifts.
- Received client appreciation for delivering high-quality work.
- Recognition from client and team leadership for contribution in project and won twelve spot awards.
- Acknowledgements received from the client for handling database projects (Daiichi DB Lock and Cerner Project Handling).
- Earned the Best Employee Award twelve times for outstanding performance.
Education
PG Diploma - Clinical Operations
Clini-India
PG - Management
University of Wales (Glyndwr University)
NEWI 09.2008 - 01.2009
MBA - HR and Marketing
Kakatiya University (St. Johns PG College)
WarangalB. Sc - Biotechnology; Chemistry and Computer Applications
Kakatiya University (CDC College)
WarangalSkills
- eTMF management
- Clinical Operations
- Data collection
- Data processing
- Data analysis
- Clinical guidelines
- Project management
- System implementation
- Process optimization
- Stakeholder engagement
- Team collaboration
Accomplishments
- Appreciation from the client for rendering 100% quality in work
- Recognition from client & team leadership for contribution in project
- Accredited with the 'Best Employee Award' for twelve times
Languages
- English
- Hindi
- Telugu
Personal Information
Date of Birth: 07/13/86
Knowledge Purview - Clinical Operations
- Functions, operations, and responsibilities of IRB / IEC
- Role of a Clinical Research Associate (CRA) in a Clinical Trial process
- Monitoring process: Site assessment, Site initiation visit, Interim site visit & Site Close out visit
- Source Data Verification Raising Queries on InForm, eCRF's, Case books, Lock / Un-Lock, Freeze / Un-Freeze CRF's and Case books
- Completing the eCRF's, systems used are Inform 4.6; 5.5, InFosario OutCome & Cerner
- Adverse Event (Both Expected & Un-Expected serious adverse events)
- Adverse Drug Reactions based on Rawlins & Thompson Classification
Timeline
eTMF Administrator
Parexel International India Pvt. Ltd
04.2016 - Current
Site support specialist - Level - II
C3i Support Service-Quintiles Global Operations Centre project
02.2010 - 04.2016
Clinical Analyst - Level II
C3i Support Service-Quintiles Global Operations Centre project
02.2010 - 04.2016
PG - Management
University of Wales (Glyndwr University)
09.2008 - 01.2009
PG Diploma - Clinical Operations
Clini-India
MBA - HR and Marketing
Kakatiya University (St. Johns PG College)
B. Sc - Biotechnology; Chemistry and Computer Applications
Kakatiya University (CDC College)