Manjunath KS
Bengaluru,KA
Summary
Dynamic Clinical Research Associate II with proven expertise at IQVIA in developing study documents and ensuring compliance with GCP standards. Skilled in interdepartmental collaboration and team training, I excel in enhancing site operations and maintaining inspection readiness, driving successful trial outcomes through effective problem-solving and accountability.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
IQVIA
Bengaluru, India (Remote)
04.2025 - Current
- Develops or contributes to the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials
- Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc…) to ensure the CRAs are informed and managing their site’s data with quality and integrity
- Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs.
- Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Responsible for training the assigned CRAs on the study and ensuring study training compliance is maintained
Clinical Research Associate
Dr Reddys Laboratories
Hyderabad, India (Remote)
09.2022 - 04.2025
- Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
- Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
- Providing training and guidance to site staff to maintain high standards of clinical trial conduct.
- Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Clinical Research Associate
Archeron Clinical Solutions
Bengaluru, India
12.2021 - 09.2022
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
Clinical Trail Associate
Navitas Life Sciences
Bengaluru, India
02.2020 - 12.2021
- Partners with the project lead/CRAs and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
- Supports the local study team in performing site feasibility and/or country feasibility.
- Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
- In liaison with the project lead, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes
- Supports the project lead or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
- Supports the project lead/CRAs in collecting and maintaining all documents throughout the trial and post trial in both eTMF (i.e., IF/LAF sections) and paper files.
Education
Doctor of Pharmacy - Pharmacy
Raghavendra Institute of Pharmaceutical Education (RIPER)
02-2020
Skills
- Study document development
- Accountability
- Interactive Management
- Report writing
- Good clinical practice
- Interdepartmental collaboration
- Team Training
- Action planning
- Coordinating site operations
- Coordinating supplies
Languages
English
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
kannada
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Tamil
Advanced (C1)
Certification
- Registered Pharmacist in karnataka Pharmacy Council
Accomplishments
- Supervised team of 04 staff members.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Work Preference
1, ["Full Time"], ["Remote","Hybrid"], ["Career advancement","Work-life balance","Company Culture","Personal development programs","Healthcare benefits","Work from home option"], []
Interests
Farming
Software
Microsoft Office 365
,CTMS
,CDMS
,ETMF
,Share Point
Timeline
Clinical Research Associate II
IQVIA
04.2025 - Current
Clinical Research Associate
Dr Reddys Laboratories
09.2022 - 04.2025
Clinical Research Associate
Archeron Clinical Solutions
12.2021 - 09.2022
Clinical Trail Associate
Navitas Life Sciences
02.2020 - 12.2021
Doctor of Pharmacy - Pharmacy
Raghavendra Institute of Pharmaceutical Education (RIPER)