Pavan Kumar Michanagatla
Bengaluru
Summary
To work in a challenging environment that provides generous opportunities for learning and achieve the goals set by the organization.
Overview
8
8
years of professional experience
Work History
Study Start-Up Manager
AstraZeneca
02.2023 - Current
- Responsible at country level for managing and conducting start-up activities in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
- Prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
- Works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
- Conduct site feasibility and planning site-level milestones till First Subject In.
- Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed.
- Responsible for site level ICF customization.
- Support site selection process by identifying and assessing potential sites/investigators
- Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process.
- Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
- Accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.
- Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
- Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Clinical Study Administrator
AstraZeneca
07.2020 - 02.2023
- Assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH- GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
- Manages and contributes to coordination and tracking of study materials and equipment.
- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g. study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
- Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites.
- Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
Centralized Study Associate II
Covance
01.2019 - 06.2020
- Assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
- Assist in the preparation of new investigator submission packages for site/regulatory submission.
- Assist the study start up teams with tasks required for site start up activities.
- Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Manage study documents and support eTMF management
- Assist in study payments (Site and Vendor)
- Track and follow up with CRAs for outstanding issues
- Perform ongoing review of patient data using available online data sources (eCRF, IWRS and Central lab etc..) to ensure consistency and correctness of data.
Process Associate (Clinical Operations Support)
Tata Consultancy Service
05.2016 - 12.2018
- Responsible for day-day administration and management of Imaging Endpoints Clinical Trial Management System.
- Review of CTMS Accounts and Contacts requests created by CTMS users
- Deactivation of duplicate Account and Contact record in CTMS by transferring studies and sites to surviving record
- Manage the profiles f or trail sites and site personnel
- Responsible for creation and configuration of new sites, studies and countries within CTMS as per study specific requirements
- Creation of Schedule of Visit Template for study by using the Study documents (Protocol, Visit Form Matrix)
- Creation of Screening and Enrolled the subjects at Site level and update Visit completion dates at Site level in CTMS f or IVRS notifications received
- Creating a Visit Costs Rate Table at Site level
- Access and modification in access level to CTMS application
- Controlling Access management of RAVE database
Education
Bachelor of Pharmacy - First Class With Distinction
KVSR Siddhartha College of Pharmaceutical Sciences
05.2014
Intermediate - A Grade
Sri Chaitanya Junior College
04.2010
S.S.C - A Grade
Sri Balachandra High School
05.2008
Skills
- Team Leadership
- Time Management
- Staff Training and Development
- Project Management
- Process Improvement
- Accelerate Study Start Up Timeline
- Planning of site startup timelines & execution
- Budget Negotiation & CSA execution
- Familiar with various clinical-related systems (VCV, EDC, iMedidata, IRT, Lab Portals etc)
- Subject Matter Expert (SME) for eTMF and Veeva Vault, with experience in managing studies in different phases (feasibility, start-up, maintenance,close-out, and archival)
Accomplishments
- Received Operations excellence award in the year 2023 (AstraZeneca)
- Received Best CSA award in the Years 2020, 2021 & 2022 (AstraZeneca)
- Received twice ‘BPS Star Performer’ award for pro-activeness and consistency in the performance (Tata Consultancy Services).
Languages
English
Telugu
Hindi
Additional Information
1) Dharmraj Sauriyaal
Principal, Clinical Development at GSK
dsauriyal@gmail.com
91 8860909431
2) Riyaz Ahmed
Global Clinical Operation Manager at Novartis
ahmedriyaz304@gmail.com
91 9160729292
3) Harikrishan Upreti
Local Study Associate Director at AstraZeneca
upreti_123@yahoo.com
91 9717102218
Timeline
Study Start-Up Manager
AstraZeneca
02.2023 - Current
Clinical Study Administrator
AstraZeneca
07.2020 - 02.2023
Centralized Study Associate II
Covance
01.2019 - 06.2020
Process Associate (Clinical Operations Support)
Tata Consultancy Service
05.2016 - 12.2018
Bachelor of Pharmacy - First Class With Distinction
KVSR Siddhartha College of Pharmaceutical Sciences
Intermediate - A Grade
Sri Chaitanya Junior College
S.S.C - A Grade
Sri Balachandra High School
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