Ashutosh Bakre
Badlapur
Summary
Hardworking and reliable clinical research professional with strong ability in centralized monitoring. Offering excellent technical abilities and management skills Highly organized, proactive and punctual with team-oriented mentality.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Functional Centralized Monitoring Lead (RBM Model)
IQVIA
Thane
08.2022 - Current
- Support CMS Lead/project team to develop monitoring strategy including monitoring triggers/thresholds, and the study specific analytics strategy, work on developing analytics based on applicable study specific plans, develop new analytics proposal as per customers demand, Perform quality reviews on the analytical output created by the team members
- Manage operational insight of the assigned project(s) and perform the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and discuss the action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
- Provide Inputs to CMS Lead/Project team, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections
- Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders
- Support in managing project resources (CRAs/CTAs/Centralized monitoring team)
- Support in performing the IP management for the assigned study to identify risk and propose mitigation plan, if any (including re-supply, re-labeling, Import/export licenses etc.)
- Contribute as Subject Matter Expert to support the CMS department in delivering trainings, perform periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required
- Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
- Analyze the complexity of the requirements and provide the EAC hours and turnaround time
- Monitor site performance and make recommendations for timely corrective actions (e.g
- Site Telephone Contact or Triggered Onsite Monitoring Visit)
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
Sr. Centralized Monitor
IQVIA
Thane
06.2017 - Current
- Serve as a Subject level Data reviewer (SLDR) and identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy
- Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
- Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified
- Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
- Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
- Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial
- Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
- Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
- Review additional information, as necessary, to determine overall readiness of the patient information for next level review
- Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points
- Review status information and data flow reports and take appropriate actions.
Medical Records Analyst
Inventurus Knowledge Solutions
Navi Mumbai
04.2016 - 05.2017
- To create and maintain electronic health record for the client physicians
- To check these records to maintain quality of the data so that physician as well as the patient can get required information from it
- To review these records for coding purpose to check for accurate diagnosis and name of the procedure or accuracy of the name of the medication given as a treatment.
Physician Partner
Sweet Pills Homeopathy Clinics
Mumbai
10.2013 - 04.2016
- To work as Physician Sweet Pills Homeopathic clinic from October 2013 to March 2016
- To record case of each patient thoroughly
- To select a correct medicine by using homeopathic method for selecting a medicine
- To look after overall patient’s management coming to clinic.
Resident Medical Officer (RMO)
Sanjivani Hospital
Kankavli
04.2010 - 06.2013
- Worked in hospital environment in wards as well as ICU, having good knowledge of all the ICU and routine hospital procedures
- Handled stressful and critical situation at the hospital environment
- Applied knowledge of pharmacology and medicine to healthcare industry routine scenarios.
Education
PG Diploma of Patent Analysis: Patent Drafting -
Indian Institute Of Patent And Trademark - Patent Agent Exam
10.2013
PGDEMS: Emergency Care Attendance -
Lifesupporters Institute of Health Science
06.2010
B.H,M,S,: Homeopathic Medicine -
MHARASHTRA UNIVERSITY OF HEALTH Sciences NASHIK
04.2009
Skills
- Sr Subject Level Data Reviewer/ functional Centralized Monitoring Lead (RBM model)
- Centralized monitor (Remote monitoring experience)
- Medical data reviewer
- Healthcare background
- Strong knowledge of ICH-GCP guidelines
- TMF specialist
- Risk based monitoring
- Team management skills
- Data management
Additional Information
Reviewing the data to check Medical congruence of the data on EDC. Reviewing investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages Reviewing all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE. String knowledge of ICH-GCP guidelines. End to end monitoring of clinical trials. Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial.
Languages
- English
- Hindi
- Marathi
Hobbies and Interests
My hobbies includes, trekking, reading books, explore new places.
My area of interest would be to explore more and more about clinical trials and to gain experience regarding every aspect of it. To become expertise in. If opportunity comes, I would like to learn data analytics.
Certification
· MCH Reg. No: 50994, 2010
· IQVIA Expert GCP Exam for Managers and Staff Interacting with Investigational Sites on 25th May, 2018
· IQVIA Expert GCP Exam for Managers and Staff Interacting with Investigational Sites on 3rd July 2020, 2020
· IQVIA Expert GCP Exam for Managers and Staff Interacting with Investigational Sites in 2021, 2021
· IQVIA Expert GCP Exam for Managers and Staff Interacting with Investigational Sites on 3rd August 2022, 2022 & 2023
Accomplishments
· Star of the quarter at Inventurus Knowledge Solutions Health (IKS Health), 2016
· Start performer of the month (IQVIA) August 2023.
Timeline
Functional Centralized Monitoring Lead (RBM Model)
IQVIA
08.2022 - Current
Sr. Centralized Monitor
IQVIA
06.2017 - Current
Medical Records Analyst
Inventurus Knowledge Solutions
04.2016 - 05.2017
Physician Partner
Sweet Pills Homeopathy Clinics
10.2013 - 04.2016
Resident Medical Officer (RMO)
Sanjivani Hospital
04.2010 - 06.2013
PG Diploma of Patent Analysis: Patent Drafting -
Indian Institute Of Patent And Trademark - Patent Agent Exam
PGDEMS: Emergency Care Attendance -
Lifesupporters Institute of Health Science
B.H,M,S,: Homeopathic Medicine -
MHARASHTRA UNIVERSITY OF HEALTH Sciences NASHIK
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