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
SheffieldBachelor’s - pharmacy
Sri Ramachandra Medical College and Research Institute (DU)
ChennaiSkills
Risk-Based Quality Management (RBQM)
Clinical Trial Oversight
Study Design
Country level oversight
Clinical trial management
Vendor Management
CRO Management
Budget Planning
Resource Planning
SME
Trainer
Mentor
TMF Management
Document Management
Team Leadership
Mentorship
Process Improvement
Veeva eTMF
Training
Mentoring
Veeva RBQM Implementation
eClinical RBQM Implementation
TMF Document Migration
Cross Functional Management
Therapeutic Areas Management
Stakeholder Relations
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)