Anubhuti Tiwari
Thane
Summary
Strategic leader with extensive team management experience. Builds training, mentoring, and development opportunities to drive performance. Shares robust resource planning and project delivery expertise.
Overview
12
12
years of professional experience
Work History
Sr. TMF Lead
ICON Clinical Research
Remote
07.2024 - Current
- To act as the Functional Lead for Trial Master File (TMF) Services, with responsibility for the delivery of all aspects of TMF.
Responsible for the setup, maintenance, and close of the TMF.
• Responsible for the complete and accurate Trial Master Files through documentation of
quality, consistency, and timely filing across all assigned clinical trials, consistent with the
Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency
and any other local authority requirements.
• Responsible for ensuring that the Trial Master Files are submission/inspection ready.
• Primary point of contact for the TMF of designated projects and responsible for developing
successful cross-functional relationships with internal and external stakeholders.
• Lead the setup of the Study in TMF system.
• Drive completeness and quality of TMF content for all assigned clinical trials until study
close out.
• Oversee documentation flow within projected timelines and determine course of actions to
prevent and remediate delays and errors.
• Lead the development and implementation of the TMF specifications, such as process and
system changes.
• Develop and foster sponsor relationships through effective TMF management and
communication.
• Primary point of contact for internal and external audits of study TMF-related queries and
support the preparation of appropriate audit and inspection responses.
• Effectively monitor and report on progress of the TMF to all stakeholders.
• Facilitate communication and interaction among study team members from the set up until
the closing of the TMF for a clinical trial.
• Apply lessons learned to the continuous improvement of documentation management practices across study teams.
Provide education, feedback, and guide Study Teams to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Maintain Study Specific Document Lists (SSDLs) at the study, country, and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical Regulatory, etc. To ensure placeholders are correctly and accurately in place for the study, and all versions and instances are filed in a timely fashion.
Conduct periodic quality reviews of Study Specific Document Lists (SSDLs) at all levels, and liaise with the Functional Line Document Owners to ensure that all findings are addressed and remediated in a timely manner.
•
Guide Study Team in the effective management of TMF when working with external vendors.
Enforce ownership and accountability of TMF documents across study teams. Ensure document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics.
Participate in company or departmental initiatives, as requested.
Mentor new employees in specified TMF lead tasks and duties, if required.
Sr. Team Lead for TMF Analyst
TCS
Mumbai
02.2021 - 06.2024
- Management of a team of TMF Analysts.
- Handled a team size of 30 TMF Analysts.
- Initiate and monitor the activities related to career development, performance management, competency development, and leave management in the team.
- Plan and execute training for the team's upskilling.
- Managing the work-related activities and ensuring compliance with the process.
- Accountable for proactive workload management within the team.
- Team-building and team-bonding activities within the team.
- Facilitating seamless communication between management and team members.
- Participation in recruitment drives.
- Prepare monthly billing and budgets.
- Maintaining, monitoring, and tracking records relating to training, productivity, compliance, and quality, along with ensuring that their individual training records are kept up to date in line with inspection readiness.
- Ownership of projects, as needed, and ensuring those are completed within budget constraints and as per agreed timelines.
- Preparation and presentation of monthly TMF metrics to the client.
- Participating in audits and inspections as required, and ensuring the team is also audit and inspection ready.
- Participating in client interactions and teleconferences to provide updates, discuss challenges, and their resolutions.
- Ensuring issues and escalations are dealt with promptly and effectively, as per the agreed escalation plan.
- Managing the team's escalations.
- Contributing to ongoing process improvements for projects handled by the team.
- Serve as the TMF SME for the client.
- Completing onboarding activities for new joiners.
- Conducting end-to-end training for new joiners.
- Acting as an SME/Trainer for new joiners.
- Oversaw training and development programs to enhance team skills and knowledge.
TMF Analyst
TCS
06.2017 - 12.2021
- Manages the set up and maintenance of electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study accountable person , Operations and science lead and functional Representatives where required
- Have an experience of handling multiple studies at a time
- Handled more than 9 studies at a time providing end to end to support to study teams
- Also worked as a part of unblinded study team, provided support for the periodic review of unblinded artefacts on CRO portal
- Working on inspection studies in preparation of inspections readiness, ensure the clinical trial documentation is consistent with trial master file agreements and applicable SOPs, ICH GCP
- Setting up EDLs and maintaining the EDLs thorough out the lifecycle of study till archival
- Performing Periodic reviews and Completeness check for the studies on ongoing basis and supporting study teams for study archival Preparation with compliance to SOP and regulatory requirements
- Leading the creation, development and maintenance of eTMF Plans, Indices, Oversight plans along with Study accountable person and functional representatives
- Provision of project management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g
- Instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards
- Conducting analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions
- Address requests in a timely and efficient manner
- Prepares the TMF for QA or Sponsor audits, leads the resolution with identifying and implementing corrective actions to findings in audit reports
- Assist in the development and delivery of training materials at the study level and provide subject matter expertise
- Understand all technical aspects of Pharma TMF system and associated tools
- Liaise with third party providers, performing as part of the cross-functional team
- Completing onboarding activities for new joiners
- Conducting end to end trainings for new joiners
- Acting as POC for new joiners
- System Worked on: etrack, CARS, Veeva Vault, eDX, PIERS, IMMS, Phlexview, wingspan.
Sr.Clinical Process Associate
Quintiles Research Technology
Bangalore
10.2014 - 06.2017
- Worked as in-house CRA, for a pilot model of CCT
- Based on Client Location in Mumbai
- Performing multiple activities(investigator payments, pre monitoring preparation, Access managements, Inform Visits validations, Follow-up with monitors for delay in data entry for visits, Green Light preparation priori to Site activation, File Reviews, Review of MVRs) in-house as a CRA
- Worked on Safety Letters Management including Periodic listings and Country specific requirements for regulatory submissions
- Accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assist the clinical team in the preparation, handling, distribution, and filing of clinical documentation and reports according to the scope of work and standard operating procedures
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
- Perform assigned administrative tasks to support team members with clinical trial execution within the Centralized Clinical Operations model
- Handing vendor management activities for various system access (Intralinks, IWRS(Rave), EDC (inform) , Inforsario, QLabs , Ceva merge System Access, investigator portal for trainings)
- Electronic trial master File Upload of document with categorization of document and document review
- Periodic review of study files for completeness
- Investigator Payments
- CTMS updates
- Essential Document Checklist for Greenlight prior to SIV
- Document Tracking
- I-Site Pack Preparation
- Helping CRA in pre-site visit preparation
- (Providing over all site status and data.) System worked on: CTMS(Seibel and Impact), Infosario Dashboard, Elvis, EEL, Intralinks, Investigator Portal, Inform, Medidata Rave, Cenduit, ALMAC and Bracket).
Associate in Clinical Research
Syntel Ltd.
04.2014 - 09.2014
- Dealing with documentation of clinical research including documents of specifics sites, study level, pharmacovigilenceand Regulatory Authorities
- Identification, naming, categorizing of all types of documents (Clinical/ Non-Clinical)
- Attribute mapping of the documents, and doing quality check of own documents before submitting to quality Analyst team
- Updating MIS, QC report, tallying work and submitting completed work on daily basis
- Once query is resolved by QC team, process and complete the document
- Conduct 100% quality check of all the documents, rectifying the errors before submitting the work for execution
- Preparing Query log and sharing it with QCier for resolving queries
- Once query resolved, having update session and sharing the resolution with processor.
Assistant Professor
Vedic Institute of Pharmaceutical Science and research
Sagar
11.2012 - 04.2013
Education
M.Pharma -
Vns Instititute Of Pharmacy Bhopal Affiliated To Rgpv Bhopal (Pharmaceutical Chemistry)
01.2012
B. Pharma -
Adina Institute Of Pharmaceutical Sciences Sagar Affaliated To Rgpv Bhopal(M.P.)
01.2010
12th -
CBSE- St. Joseph's Convent Senior Secondary School Sagar(M.P)
01.2006
10th -
CBSE- St. Joseph's Convent Senior Secondary School Sagar(M.P)
01.2004
Skills
- TMF management
- Team leadership
- Process improvement
- Stakeholder communication
- Project management
- Training development
- Audit preparation
- Vendor management
- Performance monitoring
- Task prioritization
- Multitasking
- Flexible and adaptable
- Decision-making
- Communication
- Relationship building
- Project planning
- Team building
Accomplishments
- Member of Welcome and Food committee in National Seminar Sagar (m.p)
- Won third prize in singing competition
- Won Certificates in chart competition, choral recitation and patriotic song competition in school
- Participated in Health Awareness Camp in National Pharmacy Week at Bhopal
- Coordinated in games in Ranbhoomi 2010 at VNS Group of institutions Bhopal
Additional Information
9yrs
Custom Section
Conscientious, 'Can't Say No'
Personal Information
- Date of birth: 04/03/88
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Awards
- Received an award for Star Performer in TCS
- Received Service and commitment ward in TCS
- Received an award for beyond the excellence performer
- Received an award for Best Performance in TCS
- Received a Award for team player of 2019 in TCS
- Received WWD in Quintiles for setting up a process for Safety letters distribution and tracking for the study
- Received WWD in Quintiles for leading the process for Investigator Payments and process payments for more than 400 sites in a short period of less than a week’s time
Disclaimer
I here by declare that the information given above is the correct to the best of my knowledge and belief.
Timeline
Sr. TMF Lead
ICON Clinical Research
07.2024 - Current
Sr. Team Lead for TMF Analyst
TCS
02.2021 - 06.2024
TMF Analyst
TCS
06.2017 - 12.2021
Sr.Clinical Process Associate
Quintiles Research Technology
10.2014 - 06.2017
Associate in Clinical Research
Syntel Ltd.
04.2014 - 09.2014
Assistant Professor
Vedic Institute of Pharmaceutical Science and research
11.2012 - 04.2013
M.Pharma -
Vns Instititute Of Pharmacy Bhopal Affiliated To Rgpv Bhopal (Pharmaceutical Chemistry)
B. Pharma -
Adina Institute Of Pharmaceutical Sciences Sagar Affaliated To Rgpv Bhopal(M.P.)
12th -
CBSE- St. Joseph's Convent Senior Secondary School Sagar(M.P)
10th -
CBSE- St. Joseph's Convent Senior Secondary School Sagar(M.P)
Similar Profiles
Kristy MesteyKristy Mestey
Supervisor Facilities and Administration at ICON Clinical ResearchSupervisor Facilities and Administration at ICON Clinical Research
JULIE STEPHENSONJULIE STEPHENSON
Clinical Trials Associate/Site Management Associate II at ICON Clinical Research/Vertex PharmaceuticalsClinical Trials Associate/Site Management Associate II at ICON Clinical Research/Vertex Pharmaceuticals
Salena BurroughsSalena Burroughs
Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)
Julie StephensonJulie Stephenson
Clinical Trials Associate at ICON Clinical Research/Vertex PharmaceuticalsClinical Trials Associate at ICON Clinical Research/Vertex Pharmaceuticals
Vilien DengléVilien Denglé
Business Director at RAYMOND CONSUMER CARE PVT. LTD.Business Director at RAYMOND CONSUMER CARE PVT. LTD.