Dr. Darvesh Mohammed A
Trivandrum
Summary
Clinical Research Professional with an overall experience of 3 years and a solid background in managing complex clinical trials and coordinating site monitoring activities. Strengths include strong analytical skills, effective communication, and leadership capabilities. Demonstrated success in driving process improvements, ensuring compliance with regulatory standards, and fostering cross-functional collaboration for optimal project outcomes.
Overview
3
3
years of professional experience
Work History
Associate Central Monitor
IQVIA
Bangalore
08.2023 - Current
- Developed and managed the Central Monitoring strategy for assigned clinical trials.
- Conducted regular reviews of data listings to identify potential protocol violations or trends in safety data.
- Provided guidance on monitoring activities to internal stakeholders, including Clinical Research Associates, Data Management personnel, and Clinical Scientists.
- Collaborated with external vendors to ensure timely submission of safety reports.
- Coordinated with CRAs to ensure accuracy of source documentation, adverse event reporting and resolution of queries.
- Monitored timelines for data entry into the clinical database and identified areas for improvement.
- Reviewed statistical analysis plans for adherence to regulatory requirements and study protocols.
- Prepared monthly status reports detailing progress against key milestones across multiple studies.
- Developed training materials for new CRAs on monitoring processes and procedures.
- Evaluated vendor performance metrics and worked with vendors to resolve any discrepancies.
- Provided technical advice on the development of electronic case report forms.
- Conducted risk-based assessments of study sites based on their performance metrics.
- Participated in periodic audits conducted by sponsors or regulatory agencies.
- Performed quality control checks on data collected from various sources prior to database lock.
Clinical Research Coordinator
Premier Research India Pvt Ltd
Trivandrum
12.2021 - 07.2023
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Developed and maintained accurate and timely study databases.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Monitored patient safety during clinical trials according to established guidelines.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Education
Doctor of Pharmacy - Pharmacology
Rajiv Gandhi University of Health Sciences
Mangalore11-2021
Skills
- Patient safety
- Data Management
- FDA regulations
- Site Management
- Protocol adherence
- ICH-GCP/GDP
- Database lock
- Risk based Quality Management
- Risk Signal Identification
- Safety monitoring
- Root Cause Analysis (CAPA)
- MS Excel/PowerPoint
- Veeva Vault
Languages
Malayalam
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Affiliations
- Portfolio Level:
Supporting 10+ countries
Managing 60+ active sites
Presenting 50+ country study performance calls
Preparing Site Management Risk Analysis Reports
Clinical Tools Knowledge
- Risk Assessment Categorization Tool(RACT)
- Medidata RAVE
- Cognizant Shared Investigator Platform(SIP)
- Oracle Siebel-CTMS
- eCOA(TIBCO Spotfire)
- Trackwise
- PROs Tools(Yprime)
- Labcorp Lablink+/Xcellerate Portal
- DocuSign
- IXRS
- Smart Sheet
- Veeva vault
Clinical Projects (2023-present)
- Breast cancer- A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
- Breast Cancer- A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO VERSUS PLACEBO IN COMBINATION WITH PHESGO AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Additional Contributions
- Mentor: Acted as Mentor for incoming CMs to study supporting and training them on study protocol and activities.
- QC Reviewer: Quality Check of the Central Monitoring reports delivered to customer/client.
- Remote Monitoring SME: Acted as a Remote Monitoring Subject Matter Expert of the central monitoring deliverables.
- KRI Reviewer: Identified KRI-Signalled tasks at portfolio level like AE Reporting Rate, Query Rate, Subject Visit Compliance, Major Protocol Deviation Rate, Query Response Time and RAVE data entry turn around time and implemented root cause analysis
PROFESSIONAL ACHIEVEMENTS
- Quality Improvement through Trend Detection: Enhanced trial quality by detecting trend outliers in Protocol compliance ,IMP, Sample, and ePRO management. Identified and reported protocol deviation and mitigation plans.
- Advancing Risk Analysis Methodologies: Optimized efficiency by automating Excel pivot and graph tools which enhanced the quality of deliverables
Timeline
Associate Central Monitor
IQVIA
08.2023 - Current
Clinical Research Coordinator
Premier Research India Pvt Ltd
12.2021 - 07.2023
Doctor of Pharmacy - Pharmacology
Rajiv Gandhi University of Health Sciences
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