Senior TMF Lead

5/2018 – 1/2023

◦ Performing the role of Inspection Readiness lead, act as liaison between Project management team and eTMF specialists and handling a team of around 7-8 members.
◦ Updating the Study Index and granting access to eTMF/PWF for study team members.
◦ Point of contact for Project team and eTMF specialist for query resolution.
◦ Provide Regular Updates and important communications to the study team.
◦ 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; leads the development, creates, and
maintains the eTMF Plan and index with Project Manager/Study Lead and/or sponsors.
◦ Responsible for mapping the sponsor’s TMF Index, if applicable, to the Covance TMF Index and adds/
modifies all approved TMF artifacts in the Covance TMF Index, according to Covance SOPs, and/or
sponsor SOPs.
◦ Maintains the TMF in a state of audit readiness for quality and compliance by:
◦ Visual quality checks of e-documents prior to release to confirm image clarify and readability
◦ Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every
study, ensuring context is accurate.
◦ Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each
study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan
and study milestones.
◦ Comply with metrics established for performance TMF reviews.
◦ Process and track final essential artifacts required throughout all phases of the study, in accordance
with Covance SOPs, sponsor SOPs, GCP and ICH guidelines.
◦ Manages the identification of operational and logistical issues and resolutions related to the TMF.
◦ Responsible for gathering data requested by study team to support status reports to clients.
◦ Prepares the TMF for QA or Sponsor audits, leads the resolution with identifying and implementing
corrective actions to findings in audit reports and participates in client audits and regulatory
inspections by providing guided access to the eTMF system.
◦ Review and respond to TMF content quality issues and identifies trends per study and across
programs; alerts management of trends.
◦ Proactively prepares the TMF study artifacts for export and transfer to the Sponsor at interim points
and/or at the end of the study, working with the Project Manager, Clinical Business Administrator, and
Records Management Assistant/Associate.
◦ Assists in the identification of and participates in business improvement initiatives to drive quality,
productivity, and continuous improvement of business processes
◦ Demonstrates cost awareness, understands the financial impact of their decisions, and displays
concern for cost containment and conservation of resources in activities.
◦ Implement creativity; assist in the identification of new processes, procedures, information and
opportunities to improve departmental functions.

Good clinical practice (GCP)

5/2017 – 5/2018

◦ Mentoring a team of 10 members regarding Forte Internal systems and Conducting Quality check of the calendars which were built and make edits to the calendars.
◦ Understand and interpret clinical trial study protocols to design and develop calendars for schedule of events.
◦ Design and develop case report forms for clinical trials study protocols.
◦ Develop a familiarity with Forte’s Clinical Trial Management Software (CTMS) and Electronic Data
Capture (EDC) software to utilize related functionalities in the design and development of calendars
and case reports forms.
◦ Work closely with reporting manager to complete daily/weekly calendars and/or case report forms
design to meet with pre-determined quality criteria.
◦ Creating and assigning tickets to the team members for calendar building.
◦ Handling and maintaining the regulatory documents for eReg system.
◦ Partner in customer interactions over the email to assimilate customer requirements and address
those adequately in the design and development of calendars and case report forms.
◦ Understand and utilize internal case management software and other reporting software to ensure
that daily/weekly work assignments are appropriately tracked.
◦ Develop and update work flow documents that reflect latest updates to the features and
functionalities of the CTMS and EDC, that are relate to design and development of calendars and case
report forms.
◦ Working on Budgets and coverage analysis.
◦ Actively participate in team meetings and contribute meaningfully to discussions related to specific
customer cases and/or protocols.
◦ Conduct Quality check of the calendars which were built and make edits to the calendars

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