Summary
Overview
Work History
Education
Skills
Nationality
Personal Information
Awards
Languages Known
Timeline
AdministrativeAssistant

Pavan K Yakkala

Study Manager/Project Manager/Clinical Operations Lead/TMF Lead
Ballerup

Summary

Results-driven Clinical Operations Leader with 12+ years of experience in Clinical Research & Risk-Based Quality Management (RBQM). Expertise in managing Phase I-IV clinical trials, vendor oversight, study start-up, TMF management, and cross-functional collaboration across global teams. Adept at optimizing clinical trial execution, ensuring regulatory compliance, and leading process improvements.

Overview

15
15
years of professional experience

Work History

SENIOR MANAGER- Risk based quality management

Genmab
09.2024 - Current
  • Supported Clinical Trial Teams (CTTs) in planning and execution of RBQM deliverables, including Risk Assessment Management Plans (RAMPs), Quality Tolerance Limits (QTLs), and Key Risk Indicators (KRIs).
  • Collaborated with RBM vendors for effective trial-specific RBQM setups and monitoring strategies.
  • Reviewed protocols to identify critical data and process risks, ensuring compliance with Genmab SOPs.
  • Provided training, presentations, and cross-functional knowledge sharing to foster RBQM adoption.
  • Led initiatives for process optimization, technology integration, and cross-trial learnings.
  • Supported the development and use of study management plan and risk-based monitoring specific tools and templates.
  • Actively involved in the creation of User stories for RBQM systems and coordinate with the vendor for system implementation.

Global Study Manager

GSK
01.2021 - 08.2024
  • Company Overview: Global healthcare company that researches and develops a broad range of innovative medicines and brands.
  • Driving study related activities globally and acting as a main point of contact for project deliverables end to end.
  • Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs, to achieve study objectives.
  • Oversee vendor selection, management, and performance, ensuring quality deliverables.
  • Liaise with external vendors on specific study level activities, ensuring continued monitoring of agreed delegated activities.
  • Develop, review and / or finalize high quality key clinical documents including the full protocol for external and internal use in assigned trials.
  • Mentor and coach colleagues as required.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project specific information.
  • Global healthcare company that researches and develops a broad range of innovative medicines and brands.

TMF Lead

GSK
08.2017 - 01.2021
  • Company Overview: Global healthcare company that researches and develops a broad range of innovative medicines and brands.
  • Provided operational and administrative support for the study TMF management.
  • Provided training to newcomers and refresher training to existing users & CRO’s.
  • Point of contact for FSO studies and perform management monitoring check as needed.
  • Ensure high quality and up to date TMF management in clinical study teams.
  • Own and maintain the study TMF management plan and ensures adherence by the study team members & Support the SDLs in planning and executing TMF management related activities of the clinical trial team to ensure that the TMF is in good shape and updated in a timely manner.
  • Responsible to track eTMF periodic reviews for studies and provides regular updates to the SDL/ Head TMF Operations.
  • Primary point of contact for study team members for any TMF-related question & CRO’s.
  • Support document owners to ensure TMF compliance.
  • In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system).
  • In charge, during the maintenance of the TMF that the contributors are providing their documentation in an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
  • Take the appropriate relevant actions to address gaps, issues, and risks.
  • Audit preparation related activities with regards to study-related documentation for studies in their Region providing documentation in a timely manner and assisting with CAPAs as related to TMF finding in the region.
  • Global healthcare company that researches and develops a broad range of innovative medicines and brands.
  • Took a break for 10 months due to Family reasons during this period.

Sr. Central Monitor

IQVIA
01.2016 - 08.2017
  • Establish and maintain effective project/ site communications.
  • Create and maintain relevant project documents/ trackers.
  • Ensure accurately completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project-specific information.
  • Supported in SIV, MV, and Site closeout visits.
  • Oversee Investigator site payments.
  • Reviewed, evaluate and recommend modifications to designated processes.
  • Oversee and participate in document management (creation, review, maintenance, storage, as applicable).
  • Participated in (study) team meetings and implement action items.
  • Collaborated with the project lead/team members in the creation/review of study documents.
  • Acted as point of contact for assigned deliverables for specific customers or projects.
  • Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Escalate quality issues to relevant stakeholders and/or line manager.

Remote Site Monitor - II

PPD
11.2014 - 01.2016
  • Project specific Team Lead and SPOC (Single Point of Contact) for Global RSMs in conducting various activities and coordinating with the Global Project Managers/Sponsors.
  • Performed ongoing remote data review, assess for completeness of data and any observed protocol or GCP deviations/violations.
  • Performed event-triggered real-time data review and review of key risk indicators (KRIs).
  • Performed ad-hoc clinical listings review.
  • Issued queries based on remote data review.
  • Tracked and assessed trending of violations/deviations, enrollment status, and outstanding issues.
  • Ensured study systems are updated per agreed study conventions.
  • Liaised with CRA to prompt collection of documents, reviewed data points, findings from EDC and file reviews, etc.
  • Conducted remote investigations into site performance issues at the directive of the CTM.
  • Performed electronic file reviews.
  • Conducted final reconciliation of systems such as ePIP.

Clinical Trials Assistant

D2L Pharma Research Solutions Pvt. Ltd.
08.2013 - 11.2014
  • Performed preparation and subsequent submission of study-related documents to the ethics committee for approval.
  • Managed contractual agreements with investigator sites & Vendors.
  • Coordinated with the site to conduct a study to comply with the study protocol.
  • Coordinated study initiation, conduct, and completion.
  • Performed tracking and maintaining Investigator, Vendors, and Ethics Committee payments.
  • Prepared and updated the operational logs.
  • Handled SAE related issues with the site team members.
  • Reviewed the quality of study documents.
  • Conducted co-monitoring visits with site managers.
  • Documented and submitted AE and SAEs to EC and other applicable regulatory requirements within the timelines.
  • Performed study closes with the sponsor and IRB and stores the record appropriately.

Pharmacy Technician / Team Leader

Totley Pharmacy
11.2010 - 09.2012
  • Dispensed medicines to all different types of prescriptions in very less time with high accuracy.
  • Maintained and updated control drug records accurately as per invoices and prescription inventory.
  • Performed excellent communication when dealing with patients with regards to prescription queries on the telephone and in OTC sales.

Education

M.Sc. - Pharmaceutical Analysis

Sheffield Hallam University
Sheffield

Bachelor’s - pharmacy

Sri Ramachandra Medical College and Research Institute (DU)
Chennai

Skills

Risk-Based Quality Management (RBQM)

Nationality

Indian

Personal Information

Marital Status: Married

Awards

  • Ahead together award for best performance of the year 2024.
  • Bronze award for supporting the DBL in GSK 2023.
  • Bronze award for training and Onboarding in GSK 2023.
  • Best employee in D2L Pharma.

Languages Known

  • English
  • Hindi
  • Telugu

Timeline

SENIOR MANAGER- Risk based quality management

Genmab
09.2024 - Current

Global Study Manager

GSK
01.2021 - 08.2024

TMF Lead

GSK
08.2017 - 01.2021

Sr. Central Monitor

IQVIA
01.2016 - 08.2017

Remote Site Monitor - II

PPD
11.2014 - 01.2016

Clinical Trials Assistant

D2L Pharma Research Solutions Pvt. Ltd.
08.2013 - 11.2014

Pharmacy Technician / Team Leader

Totley Pharmacy
11.2010 - 09.2012

M.Sc. - Pharmaceutical Analysis

Sheffield Hallam University

Bachelor’s - pharmacy

Sri Ramachandra Medical College and Research Institute (DU)

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Pavan K YakkalaStudy Manager/Project Manager/Clinical Operations Lead/TMF Lead