MovieFanati User
@moviefanatiuser
eTMF Lead at Precision for Medicine, implementing n8n automation to streamline clinical trial document routing and status updates.
SerbiaWhat I'm looking for
At Precision for Medicine, I implement workflow automation in eTMF operations, using n8n to streamline document routing and status updates while maintaining regulatory compliance.
I develop Study TMF Plans and Project TMF Document Indexes across multiple trials, monitor documentation quality, and coordinate study close-out reviews. I also serve as a subject matter expert for event management and AI initiatives within TMF operations.
At OPIS Research, I managed electronic trial master file operations, performing quality checks and managing document indexing and finalization. I also contributed to TMF plans and trained new users on Montrium systems.
Earlier, I worked in clinical study compliance at Syneos Health, and held team leadership roles at Hyperoptic and NCR Coorporation. I'm now transitioning from regulatory compliance to full-time automation engineering, bringing clinical operations knowledge and process optimization experience to broader automation challenges.
Experience
Work history, roles, and key accomplishments
eTMF Lead II
Precision for Medicine
Apr 2024 - Present (2 years 7 months)
Managed eTMF operations for clinical trials, ensuring regulatory compliance and high-quality documentation. Drove process improvements and implemented automation solutions to streamline workflows.
eTMF Specialist
OPIS Research
Mar 2023 - Apr 2024 (1 year 1 month)
Managed electronic trial master file operations with focus on quality control and document management processes for clinical studies.
TMF Compliance Specialist
Syneos Health
Apr 2021 - Mar 2023 (1 year 11 months)
Specialized in clinical study compliance, focusing on quality review processes and administrative task management for ongoing studies.
Quality Team Lead
Hyperoptic
Sep 2020 - Apr 2021 (7 months)
Organized balanced workload for Compliance department to meet business performance targets and ensure business continuity. Led training and GDPR awareness campaigns.
Supervised a team of 75 Support Specialists on a daily basis, mentoring and guiding employees to ensure product knowledge and performance. Generated and reviewed daily/weekly campaign reports to track performance against targets and KPIs.
Education
Degrees, certifications, and relevant coursework
CODE Academy
QA & Testing Fundamentals, QA & Testing
2023 - 2023
Completed QA & Testing Fundamentals training at CODE Academy from January to April 2023.
Singidunum University
Bachelor's Degree, Ecological Management and Sustainable Development
2011 - 2016
Bachelor's Degree in Ecological Management and Sustainable Development from Singidunum University, Belgrade, Serbia, from 2011 to 2016.
Tech stack
Software and tools used professionally
Availability
Location
SerbiaAuthorized to work in
Salary expectations
Job categories
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