GOPALA RAO CHELIKANI
Toronto,Canada
Summary
Dynamic Clinical Operations Specialist with a proven track record at WorldCare Clinical, adept in clinical project management and regulatory compliance. Skilled in Medidata Rave and electronic data capture, I excel in driving project success and fostering team collaboration, ensuring timely and accurate delivery of clinical trials while adhering to good clinical practices.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Sales Development Representative-Intern
Nucliq Biologics Inc
, Canada
02.2025 - 04.2025
- Executed sales initiatives and outreach strategies under supervisor direction.
- Researched prospects online to generate qualified call lists for sales team.
Consultant-Clinical Operations
Vivalink
, USA
03.2023 - 01.2025
- Organized and validated clinical data for regulatory submissions, ensuring accuracy for 510(k) applications and CE marking documentation.
- Contributed to development and maintenance of clinical data within technical files and regulatory dossiers.
Clinical Operations Team Lead
WorldCare Clinical
Hyderabad, India
07.2021 - 03.2023
- Designed targeted training plans to address knowledge gaps within team.
- Managed project portfolio from conception through completion, ensuring timely delivery within budget constraints.
Clinical Operations Coordinator
WorldCare Clinical
Hyderabad, India
04.2021 - 07.2021
- Delivered comprehensive administrative support to project teams throughout clinical trial activities.
- Coordinated site activation and training for Investigator Site personnel to enhance compliance.
Clinical Project Coordinator
Imaging Endpoints
Hyderabad, India
05.2020 - 04.2021
- Facilitated project start-up activities, contributing to effective life cycle management.
- Executed clinical data entry and verification, ensuring accuracy and integrity.
Clinical Operations Specialist
Hetero Drugs
Hyderabad, India
09.2017 - 05.2020
- Ensured accurate setup and maintenance of clinical trial management systems and Trial Master File.
- Updated data, timelines, milestones, and ethics committee authorizations for all countries and sites.
Investigator Payments Specialist
Parexel
Hyderabad, India
09.2015 - 09.2017
- Reviewed study protocols, contracts, and agreements to ensure compliance with regulations.
- Analyzed budget grid for accuracy, executing contract budget grids for Impact Harmony values.
Education
Masters - Clinical Research
Northeastern University
Toronto, Canada04-2025
Master of Pharmacy - pharmacology
JNT University
Hyderabad, India01.2016
Bachelor of Pharmacy -
JNT University
Hyderabad, India01.2014
Diploma in Pharmacy -
SBTET
AP, India01.2008
Skills
- Medidata Rave and Oracle Clinical
- Electronic data capture
- Clinical project management
- Clinical trial design and coordination
- Regulatory compliance
- Microsoft Office Suite proficiency
- Data management and interpretation
- Medical coding expertise
- Records management strategies
- Protocol development and compliance
- Drug development process knowledge
- Good clinical practice adherence
- Clinical monitoring skills
- Pharmacovigilance expertise
Certification
- TCPS 2: CORE 2022
- ICH GCP
- RAPS Member
Timeline
Sales Development Representative-Intern
Nucliq Biologics Inc
02.2025 - 04.2025
Consultant-Clinical Operations
Vivalink
03.2023 - 01.2025
Clinical Operations Team Lead
WorldCare Clinical
07.2021 - 03.2023
Clinical Operations Coordinator
WorldCare Clinical
04.2021 - 07.2021
Clinical Project Coordinator
Imaging Endpoints
05.2020 - 04.2021
Clinical Operations Specialist
Hetero Drugs
09.2017 - 05.2020
Investigator Payments Specialist
Parexel
09.2015 - 09.2017
Masters - Clinical Research
Northeastern University
Master of Pharmacy - pharmacology
JNT University
Bachelor of Pharmacy -
JNT University
Diploma in Pharmacy -
SBTET
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