TMF Lead I

7 days ago

Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.


The position provides process, control, coordination, and approval of clinical trial documents. The position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
Is the primary TMF Delivery Center point person for assigned studies.
Conduct TMF-specific Kick-off Meeting with Sponsor and Fortrea project team to establish expectations, requirements & deliverables in line with ICH and to support scope build

Oversees the planning, set-up, maintenance, QC, and, closure of the study TMF for clinical studies, in accordance with agreed TMF processes (Fortrea or sponsor SOPs) working with key study personnel as identified.

Confirms internal and external system access needs

Accountable for the creation and maintenance of the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor.

Maintenance of access within the TMF system in collaboration with the TMF access management team.
Compliance with current Fortrea eTMF system training requirements. Where needed, complete required eTMF system training for sponsor systems.
Provide project team training on study specific TMF plan and Index or other Trainings, as required.

Ensure deviations from standard Fortrea TMF business process and operating model are documented accordingly in TMF Plan or other applicable document.

Document and escalate all identified compliance issues. Follow-up findings until resolution/CAPA implementation.
Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead.
Receive sponsor-specific report requests (confirm required, within scope). Work with appropriate TMF operational services and TMF system experts to evaluate the feasibility of sponsor-specific report requests and ensure development and delivery as appropriate

Oversees the preparation of the TMF for QA or Sponsor Audits and Inspections, and participates in Audit & Inspections as required.

Responds to any CAPAs issued on guidance with the Management Team.
Maintains the TMF in a state of audit/inspection readiness by:
o Completing the Initial matching of Index with Expected Document List (EDL) update for requiredness & count, in collaboration with leads from each functional group within the study
o Ensure ongoing "real-time" EDL maintenance updates are maintained by each functional group per assigned study
Oversee timely kick-off of TMF Review Workflows on or before 25th Day of the Milestone Release

Revised:
January 2023 Page 3 of 7
Responsible for monitoring completeness of the study TMF at each Milestone Review. Escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members. Setting up a monthly meeting with the Study Team.

Oversee the processing of essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs (as applicable), GCP, and ICH guidelines.

Leads Project Review/Governance debrief and set up meetings on the same.

Reports on Portfolio and Study Level Key Performance Indicators (KPIs) as applicable, monitors study metric compliance, and provides remediation guidance as required.

Identifies trends per study and across programs; alerts management of trends as applicable
Review and respond to TMF content quality issues
Assists the TMF Remediation team as and when required for assigned studies
Attend and/or present at internal or external study team meetings as required
Maintain awareness of study events and the associated documentation requirements
Maintains effective internal and external communication
Collaborates with all members of TMF Operational Services
Contributes overall client satisfaction
Maintains an understanding of applicable regulatory requirements
Contributes to business development opportunities
Act as the Point of Contact for Technical Issues faced by other TMF DC roles (e

g:
Classifiers, Reviewers) during maintenance of the TMF in the UCV system.
Performs other related duties as assigned
Offers support as required

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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