Jayesh Joshi
Hyderabad,TG
Summary
Highly accomplished Clinical Data Management professional with 10+ years of experience in leading and executing end-to-end data management activities across diverse therapeutic areas. Proven expertise in developing and implementing data management strategies and ensuring data integrity. Adept at managing cross-functional teams and fostering collaborative relationships to achieve project milestones and regulatory compliance.
Overview
11
11
years of professional experience
Work History
Associate Data Team Lead
IQVIA RDS (India) Pvt Ltd
08.2023 - Current
- Serving as primary point of contact for customer on clinical data management deliverables
- Providing project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
- Providing justification and perform direct negotiations with customer, e.g., timelines, financial, process, resource
- Maintaining strong customer relationships
- Ensuring open communications with customer and Quintiles management to manage and meet contractual obligations
- Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
- Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
- Support DM service delivery with comprehensive DM process and technical expertise in executing projects
- Serving as the escalation point for unresolved data issues, works with client data managers, vendors, and internal team members for resolution
- Working with functional managers to ensure appropriate resources are assigned to meet project deliverables
- Create and review and sign off on all data management plan (DMP) documents
- Implement proactive quality management plans across multiple projects
- Track service performance and provide leadership to identify root causes of issues and implement remedial actions
- Recognizing and sharing the lessons learned and best practices at the trial level
- Serving as Subject Matter Expert (SME)
- Provide leadership and expertise in a specific CDM task or technology
- Maintain internal tracking databases and systems
Clinical Data Manager
Novartis Pharmaceuticals India
05.2019 - 07.2023
- Responsible for providing data management input to clinical trial teams, providing support and may function as back up Trail Data Manager to studies required for global clinical trials
- Performs DM activities for startup of a study including preparing of CCG’s where needed, Data Handling Plan (DHP), Data Review Plan (DRP) and Performing User Acceptance Testing (UAT) as applicable
- Under supervision ensures consistency of assigned trials with program level standards
- Performs ongoing review of all data generated from the clinical study including Third Party and Local lab as well as SAE reconciliation where applicable
- Performs data review by exporting J-review reports and SAS reports
- Verifies and tracks eCRF completion including Query resolution and provides Study status updates in the form of Metrics to Global Trial Director and Clinical Trial Team (CTT) as needed
- With the support of Trail Data Manager develops proposals to resolve issues that may occur during the running of assigned trials
- Performing Database Lock activities as per the provided check list, relevant SOPs, and guidelines
Clinical Data Analyst - 1
PAREXEL International India Pvt. Ltd. 1
07.2014 - 04.2019
- Planning, coordinating, and executing the DM tasks of the project and making sure the studies meeting the organization expectations
- On shore/Off-shore and in-house Team Communication: Study communication with Project Team (Study Team Lead, Data Management Lead, Clinical Team, Statistical and Database Programmers)
- Generation of DM Metrics reports and Study status metrics for sponsor review
- Perform Data Management activities in Clinical Databases to ensure accuracy, consistency and completeness of the data
- Data validation on system (review, generate/close query, reconciliation, query management etc.)
- Off-line listing review and generate queries on system
- Reconciliation of external data such as Central lab data, Local lab data, IVRS data, ECG data etc
- Medical tracker and Medical Queries
- Identify and report protocol deviations/violations
- Dataset review during the major deliverables
- Freezing and Locking Activities
- Perform early and final database QC activities and perform additional data review activities to provide high quality data
- Maintenance of Subject tracker and DM status reports- Tracking subject data to give the exact status of the subject in the trial
- Creation and maintenance of study files and other study documents in Organization specific storage database
- Knowledge sharing sessions through presentations on data processing and project specific trainings on process changes
Education
PG Diploma in Clinical Data Management -
Six Sigma Institute of Clinical Research Organization
06-2014
Master of Pharmacy (Pharmaceutics) - Pharmaceutics
Jawaharlal Nehru Tech University
05.2014
Bachelor of Pharmacy -
Osmania University
05.2012
Skills
- Clinical data management
- Data analysis
- Vendor Reconciliation
- User Acceptance Testing
- Migrations
- Training and mentoring
Summary Of Experience
More than 10 years of experience working with Contract Research Organizations (CROs) and Sponsor, expertly gathering, and analyzing data for highly confidential clinical trials. Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the Data-Management lifecycle. Advanced skills in EDC systems (Rave, Inform and Data labs), Expert in Data Management activities.
Therapeutic Area Expertise
Multiple Myeloma, Thyroid Cancer, Small Cell Lung Cancer, Alzheimer’s Disease, Multiple Sclerosis, Hidradenitis Suppurativa, Severe Aplastic Anemia
Clinical Data Management Expertise
- Medidata Rave (Rave X and Rave Classics)
- Veeva vault
- DataLabs
- InForm
- JReview
Languages
English
Hindi
Telugu
Marathi
Personal Information
Date of Birth: 08/18/90
Disclaimer
I hereby declare that all the above particulars are true to the best of my knowledge.
Timeline
Associate Data Team Lead
IQVIA RDS (India) Pvt Ltd
08.2023 - Current
Clinical Data Manager
Novartis Pharmaceuticals India
05.2019 - 07.2023
Clinical Data Analyst - 1
PAREXEL International India Pvt. Ltd. 1
07.2014 - 04.2019
Bachelor of Pharmacy -
Osmania University
PG Diploma in Clinical Data Management -
Six Sigma Institute of Clinical Research Organization
Master of Pharmacy (Pharmaceutics) - Pharmaceutics
Jawaharlal Nehru Tech University
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