Power Query, Power BI and Statistical analysis System
Shivaji Patil
Associate Centralized Monitoring Lead
Badlapur
Summary
Dynamic clinical research professional with 11 year of experience in clinical research, excelling in risk assessment and mitigation strategies. Proven track record in team management and collaboration, leveraging advanced analytical skills in Power BI and Power query. Recognized for enhancing study quality and integrity while fostering a culture of ownership and adaptability within teams.
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
11
11
years of professional experience
3
3
Languages
Work History
Associate Centralized Monitoring Lead
IQVIA
11.2022 - Current
- Got Promotion on Nov 2022 to Associate Centralized monitoring lead.
- Provide support to CMS lead as protocol, SOPs, COP.
- Work on Finance related information and provide input in EAC forecast as per functional budget
- Perform functions from start-up to final deliverables including close out.
- Contribute to development in study management plans including risk assessment and mitigation plan, tools and document template along with plans which maintain quality and integrity of study.
- Perform quality review and develop analytic output, including monitoring and analytic strategy.
- Manage study metrics and provide input for key decision, process improvement, issue escalation and work load projections.
- Identify risk and propose mitigation plan.
- Support managing process resource as per budget and project need.
- Conduct periodic review of site level KRIs and manage site level risks.
- Coordinate with internal and external stakeholders.
- Create and maintain relevant project document and tracker.
- Review site visit report per annotations, SOP and guidance documents and identify issue and escalate the same to clinical leads.
- SME on integrated risk-based monitoring study budget.
- Act as a mentor, coach for Junior CMS members and foster ownership and collaboration with team.
- Act as a technical solution specialist point of contact by implementing analytical skills by using Power query, Power BI and excel advance.
Sr. Centralized Monitor
IQVIA
07.2017 - 10.2022
- Got promotion on Jul 2021 to Senior Centralized monitor.
- Worked in Start-up, Conduct and closeout clinical trial phases 2,3 and 4.
- Subject safety monitoring review in Inform.
- Conducting remote monitoring visit, writing monitoring visit report in CTMS.
- Support CRA during site monitoring visit.
- Remote site management.
- Coordination with internal and external stakeholders
- Assist in developing required basic data analytics and
- Perform the trend analysis.
- Perform complex process that eventually result in high quality deliverables within project timelines.
- Prepare informative site pack for site visits.
- Vendor Management.
- Review and maintain eTMF.
- Review investigator site file.
- Follow up for action item, missing pages, open queries.
- Conduct periodic review of site level KRIs and historic site performance according to central monitoring plan.
- Perform IP management for assigned study to identify risk and proposed mitigation.
Senior Clinical Research Associate
Mascot Spin Control
11.2016 - 07.2017
- Initiation of document for EC submission.
- Preparation of statistical plan for study design.
- Study conduct
- Study monitoring visits
- IP accountability.
- Coordination with investigator
- Perform statistical analysis.
- Performed various statistical analysis by SAS.
- Perform statistical analysis
Senior Research Fellow
Sion and KEM Hospital
08.2014 - 01.2015
- Develop trauma registry for Indian Government.
- Data Capture and Data validation.
- Patient visit and f/ups and EDC reporting for Concomitant medication
- AIS coding to injury description.
Clinical Research Coordinator
Department of Surgery, Sion Hospital
10.2013 - 07.2014
- Support in site selection and initiation of clinical trial site.
- Coordination in submission and approval of clinical trial documents.
- Patient visit and f/ups and EDC reporting for Concomitant medication
- Maintain ISF.
- EDC data entry.
Education
Master's in Pharmacy - Quality Assurance
Government College of Pharmacy
Amravati, India 04.2001 -
B. Pharmacy -
S.N.D. Pharmacy College
Nashik, India 04.2001 -
Diploma in Pharmacy -
Diploma College of Pharmacy
Pune, India 04.2001 -
12th -
KBVP Jr College
Solapur, India 04.2001 -
10th -
KBVP Jr School
Solapur, India 04.2001 -
Skills
Teamwork and collaboration
Customer service
Microsoft office
Team management
Problem-solving
Time management
Flexible and adaptable
Software
Playing Cricket
Participated in Organizational level sports mainly in Cricket
Timeline
Associate Centralized Monitoring Lead
IQVIA
11.2022 - Current
Sr. Centralized Monitor
IQVIA
07.2017 - 10.2022
Senior Clinical Research Associate
Mascot Spin Control
11.2016 - 07.2017
Senior Research Fellow
Sion and KEM Hospital
08.2014 - 01.2015
Clinical Research Coordinator
Department of Surgery, Sion Hospital
10.2013 - 07.2014
Master's in Pharmacy - Quality Assurance
Government College of Pharmacy
04.2001 -
B. Pharmacy -
S.N.D. Pharmacy College
04.2001 -
Diploma in Pharmacy -
Diploma College of Pharmacy
04.2001 -
12th -
KBVP Jr College
04.2001 -
10th -
KBVP Jr School
04.2001 -
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