Mohammed Vikhar Ahmed
Gaganpahad,TG
Summary
Experienced Clinical Research Associate with over 3 years of expertise in managing and monitoring clinical trials. Adept at ensuring compliance with regulatory requirements and Good Clinical Practice. Recognized for excellent communication skills and the ability to handle challenging tasks confidently.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Associate- Assistant Manager Grade
JSS Medical Research Asia Pacific
2023.11 - Current
- Responsible for conduct of Qualification visits, Site Initiation Visit, Monitoring Visit, and Closeouts visit.
- Would be the first point of contact for Communication with Investigators and site personnel for the study assigned.
- Preparation of PowerPoint presentations for investigator meetings and Site Initiation visits.
- To ensure EC dossier submission at sites, approval, and site initiation visit (Remote / On-site).
- To ensure targeted recruitment.
- Coordinate the movement of Laboratory samples and IP shipment to the Trial Sites.
- Prepares Confirmation letters, follow-up letters, and reports for the respective visits as per the SOPs and shares with the site and Sponsor as required.
- Monitor study progress to ensure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practice.
- Monitor and track patient enrolment and study progress.
- Ensuring the data entry/CRF filling and following-up visits of subjects as per the protocol.
- Follow up with the coordinator for query resolution.
- To ensure the interim safety reports and interim study reports are provided to EC as per the governed regulatory body.
- Ensure collection of all data and remaining study supplies for return to the Sponsor/JSS.
- Prepare the site for possible Internal and/or Client Audits / Inspections.
- Archival with an Inventory list of Source documents/ CRFs/ CTM/ Others at the site.
Clinical Research Associate
Croissance Clinical Research
2021.08 - 2023.11
- Conducted qualification, site initiation, monitoring, and closeout visits.
- Managed communication with investigators and site personnel.
- Prepared presentations for investigator meetings.
- Ensured compliance with regulatory requirements and guidelines.
- Monitored patient enrollment and study progress.
- Coordinated the movement of laboratory samples and IP shipments.
- Prepared necessary documentation and reports for site and sponsor communication.
Education
Master of Pharmacy -
Anwar-Ul-Uloom College of Pharmacy, Osmania University
Hyderabad, Telangana05.2022
PG Diploma in Clinical Research -
Clinosol Research Pvt. Ltd.
Hyderabad, Telangana08.2019
Bachelor of Pharmacy -
Deccan School of Pharmacy, Osmania University
Hyderabad, Telangana05.2019
Skills
- IMPACT CTMS
- Veeva Vault eTMF
- iMedidata Rave EDC
- REDCap EDC
- Clinion Clinical Trial Solutions EDC
- OctalSoft EDC
- iMedidata RTSM
- Endpoint IRT
- Octalsoft IWRS
- MS Office
Certification
- Certificate of Completion for PG Diploma in Clinical Research.
- Certificate of Completion for completing Training in iMedidata Rave EDC, iMedidata Rave RTSM, Endpoint IRT, IMPACT CTMS, Veeva Vault eTMF.
- Certificate of Completion for Completing GCP E6 (R2) and GCP for Social and Behavioral Research in Clinical Trials by the National Institute of Health.
Languages
English
Hindi
Telugu
Professional Highlights
- GPAT 2020 Qualified, NTA Score- 93.54%
- Awarded as Pinnacle Performer of the Year 2023 – Clinical Operations at Croissance Clinical Research.
- Awarded as JSS Star of the Month MAY 2024 at JSS Medical Research Asia Pacific.
Personal Information
- Date of Birth: 11/04/95
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Projects
- Infectious Disease: Invasive Fungal Infection, Phase Ib, India.
- Gynecology: Endometriosis, Phase III, India.
- Endocrinology: Type 2 Diabetes, Phase III, India.
- Oncology: Cervical & Ovarian Cancer, Phase II, India.
- Wound Care: Wound Management, Phase IV, India.
- Immunology: Cholera, Phase III, Nepal.
- Immunology: COVID-19, Phase II & Phase III, Nepal, Rwanda, Mozambique, Madagascar.
Disclaimer
I, Mohammed Vikhar Ahmed, Hereby Declare That the Information Contained Herein Is True and Correct to The Best of My Knowledge and Belief.
Timeline
Clinical Research Associate- Assistant Manager Grade
JSS Medical Research Asia Pacific
2023.11 - Current
Clinical Research Associate
Croissance Clinical Research
2021.08 - 2023.11
Master of Pharmacy -
Anwar-Ul-Uloom College of Pharmacy, Osmania University
PG Diploma in Clinical Research -
Clinosol Research Pvt. Ltd.
Bachelor of Pharmacy -
Deccan School of Pharmacy, Osmania University
- Certificate of Completion for PG Diploma in Clinical Research.
- Certificate of Completion for completing Training in iMedidata Rave EDC, iMedidata Rave RTSM, Endpoint IRT, IMPACT CTMS, Veeva Vault eTMF.
- Certificate of Completion for Completing GCP E6 (R2) and GCP for Social and Behavioral Research in Clinical Trials by the National Institute of Health.
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