Priyanka Raman
Senior Clinical Document Specialist
Hyderabad
Summary
Highly experienced, team focused & Object Oriented Clinical Research Professional with overall 13 years of experience at site level and Sponsor level on Trial Master File, Clinical Trial Documentation, Inspection readiness, Quality focused & vendor management. Proven ability to lead cross-functional teams of complex multiple projects. Supported around 100+ studies on CDS and Sr. CDS activities.
Overview
13
13
years of professional experience
4
4
Certifications
Work History
Senior Clinical Document Specialist
Novartis Healthcare Pvt Ltd
Hyderabad
09.2018 - Current
- Contributed to various team level and site level initiatives (STOEcomm)
- Developed Onboarding checklist for associates who completed their onboarding trainings
- Delivered projects with high complexity, time bound and not limited to complex projects like fGSK remediation, Gyroscope, ORION-8
- Worked on PQ Testing for fGSK studies
- Subject Matter Expert for fGSK studies by streamlining the process on document review and quality, document filing and query resolution
- POC for first Pilot BD & L project (Gyroscope) in cascaded plan and strategy for Quality review for 5 studies by developing TMF GAP tracker and leading a team who is performing QR activity for Gyroscope
- Performed TMF health and risk assessment appendix 1 & 2 (spot check for 40 essential TMF documents)
- Developed an outcome report for TMF health and risk assessment and filed in eDMS system (SUBWAY) for Gyroscope project
- Lead the QR Plan development for Gyroscope based on the summary obtained from TMF Health and Risk assessment
- Developed QR strategy standard text for BD & L project
- Working on TMF Health and Risk assessment overview chart which helps the team internally for reference
- Overseeing QR activity performed by 5 CDS's
- Contributed in revising the appendix 1 & appendix 2 of TMF risk and Health assessment document
- Extended my support on performing quality review in eDMS system (SUBWAY) for ORION-8 study for TMF documents at HQ, country and Site level
- Performed spot check on import/export license, Sponsor study record (SSR) and Study Lead QC checklist for 13 fGSK studies as per request from MHRA
- Shared experience and knowledge on TMF Health and Risk assessment for associates who are assigned on BD & L projects
- Supporting outsourcing studies in developing TMF Plan as per Novartis standards
- Job Shadowing on all CDS activities and mentoring new joiners
Clinical Document Specialist
Novartis Healthcare Pvt Ltd
Hyderabad
07.2013 - 09.2018
- HQ TMF TOC - Generation, maintenance (including follow up for documents) and finalization of Trial Master File Table of Contents (TMF TOC) – Headquarters (HQ) level in document management system, for assigned trials
- Provided on-boarding training on HQ TMF TOC and eTMF/eTRAC activity
- FPP & CSR - created a guidance document for CSR appendices and FPP checklist
- eTMF tracker reconciliation for CSR appendices and financial disclosure reporting – tracking, reconciling and follow up for essential TMF documents for all sites/investigators (supports completion of CSR appendices 16.1.3 and 16.1.4), for all assigned trials
- Interfacing with document publishers on behalf of clinical teams to ensure availability of ‘published’ quality documents that are delivered according to timelines and technical specifications.
- EOT Checklist completion – Generation, population and follow up for finalization of the checklist to confirm and allow formal close-out of the trial
- Collection and verification of the drug batch information received per patient for CSR appendix (16.1.6) documentation for trials without IRT tracking
- Maintenance (including follow up) of the non-IRT drug supply tracking tool to help the clinical teams to have a clear overview of the drug inventory status at the country level, for selected studies which do not utilize an IRT system for drug supply management. This requires close collaboration with country representatives, Drug Supply Management (DSM) and Study Lead
- Provided onboarding for the 6 new associates,Prepared, and executed an onboarding plan
- Supported on inspection readiness fGSK studies
- Have hands on experience in FD module activity for study AIN457F2301 It was great collaboration with assigned CDS on eTMF reconciliation and with study team on obtaining the required information to complete the document
Clinical Research Coordinator
Care Hospitals
Hyderabad
08.2011 - 06.2013
- Performed Clinical coordinator responsibilities in studies under various therapeutic areas Pulmonology, Cardiology, Hematology(Chronic Obstructive Pulmonary Diseases, pulmonary arterial hypertension in children, Immune Thrombocytopenia, Myocardial Infraction or Ischemic Stroke in Patients with Type 2 Diabetes)
- Assisting the PI from the Feasibility to Study Completion, Conducting the subject visits as per the protocol & regulatory requirements with the PI, Preparation and implementation of study specific processes according to the protocol, Screening and enrollment as per eligibility criteria of study protocol with the PI
- Facilitate biological sampling & Central Labs procedural training, Arrange dispatch and shipment of samples in projects and IP storage and accountability
- Trained in IVRS and IWRS, Trained and Experienced in Electronic data capturing (Inform 5.0 and OC-RDC 4.5.3)
- Documentation of Informed Consent Process, Source data, completing Case Report Forms and Data Clarification Forms (DCF’s), Participate in monitoring
- Adverse Event and Serious Adverse Event reporting, Ethics Committee Submiss
Clinical Research Coordinator
Global Hospitals
Hyderabad
05.2010 - 06.2011
- Knowledge in ICH GCP Guidelines
- Assisting the PI from the Feasibility to Study Completion
- Facilitate biological sampling & Central Labs procedural training
- Arrange dispatch and shipment of samples
- IP storage and accountability
- Conducting the subject visits as per the protocol & regulatory requirements with the PI
- Preparation and implementation of study specific processes according to the protocol
- Screening and enrollment as per eligibility criteria of study protocol with the PI
- Trained in IVRS and IWRS
- Trained and Experienced in Electronic data capturing (Inform 5.0 and OC-RDC 4.5.3)
- Documentation of Informed Consent Process, Source data, completing Case Report Forms and Data Clarification Forms (DCF’s)
- Adverse Event and Serious Adverse Event reporting
- Ethics Committee Submissions
- Maintenance of Investigator site files
- Participate in monitoring
Education
P G Diploma in Clinical Research - Clinical Reasearch
Kriger International Institute OfClinical Research
Canada 04.2001 -
Bachelor's of Pharmacy - Pharmacy
Vikas College of Pharmacy
Warangal 04.2001 -
Skills
Analytical thinking
undefinedCertification
• Completed Online Clinical Research Professional Development Program from Kriger Clinical Research Center, Canada.
Accomplishments
- Received appreciation award for releasing an FPP checklist for a boot camp study
- Received appreciation award for creating a guidance document for CSR appendices and FPP checklist
- Represented CRS group in International Forum meet of Safety Members meeting.
- Provided an overview to the Medical Affairs team about the Trial Master Documentation process at HQ level
- Nominated as a part of STOEcom member for year 2016
- Received star award for providing back up support
- Provided onboarding for the new associates, Prepared and executed an onboarding plan
- Finalized an onboarding checklist for the CDS team.The template will be used by new joiner to fill in all the check points once their onboarding is completed and file the signed copy in CDS share point
- Mentoring to peer collogues on CDS activities, providing extensive support in attending study meetings
- Received start award for extensive support on fGSK studies in scope of MHRA inspection
- Received Global recognition SPARK award in 2022 for the contribution to the fGSK remediation project. It has been a challenging project which required a tremendous effort to complete on time
- Received SPARK AWARD in 2022 for Gyroscope project which is a pilot for the new guidance TMF Health and Risk assessment
- Got appreciation during an sponsor audit for FUTURE 3 Study & NGAM 02 Study
- Attended for subject retention meeting which was conducted in AstraZeneca, Bangalore (SAVOR Study)
- Attended “GCP WORKSHOP” organized by the Investigator Council of Indian Society for Clinical Research at Hyderabad.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Senior Clinical Document Specialist
Novartis Healthcare Pvt Ltd
09.2018 - Current
Clinical Document Specialist
Novartis Healthcare Pvt Ltd
07.2013 - 09.2018
Clinical Research Coordinator
Care Hospitals
08.2011 - 06.2013
Clinical Research Coordinator
Global Hospitals
05.2010 - 06.2011
P G Diploma in Clinical Research - Clinical Reasearch
Kriger International Institute OfClinical Research
04.2001 -
Bachelor's of Pharmacy - Pharmacy
Vikas College of Pharmacy
04.2001 -
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