TFS HealthScience

•	Lead a team of TMF Associates, providing strategic guidance on TMF oversight, document management, and quality compliance.
•	Conduct regular quality reviews and spot-checks, achieving a 98% TMF completeness score.
•	Assisting and leading activities associated with quality controls, audits, and regulatory inspections in 
relation to the TMF.
•	Enhanced TMF quality assurance by implementing a streamlined document control process, leading to a 20% improvement in audit readiness.
•	Successfully led the final eTMF processing and reconciliation for a major CNS study, ensuring compliance with regulatory guidelines and facilitating a smooth transition to study close-out.
•	Facilitate communication between study teams and sponsors, enhancing collaboration and issue resolution.
•	Generate TMF health metrics reports and dashboards for the Internal Study Operational teams and sponsors by providing insights on TMF progress and quality issues.
•	Perform Quality Checks (QC2 and QC3) and maintenance of eTMF, follow up issues until resolution.
•	Manage risk assessments of expected document lists (EDLs) and collaborate with cross-functional teams to identify and mitigate TMF gaps (reconcile EDLs to avoid duplicates and discrepancies)
•	Update TMF Plans and TMF index.
•	Provide education, feedback, and support to study teams to build knowledge and awareness of good document management practices and apply lessons learned across studies (training and mentoring activities for the new and current study members).

Senior Trial Master File Associate

Syneos Health

•	Maintained audit readiness of regulatory documentation according to Essential Regulatory Document Guidelines and Trial/Project Master File Plan 
•	Facilitated effective communication as a liaison with key investigators throughout the study-specific project.
•	Proficiently utilized electronic trial master file systems ensuring document QC, approval of study-required documents and quality checks.

Registry Management Associate I

Served as Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF. 
•	Provided expert TMF oversight for global projects in oncology and neurology using Veeva Vault at an advanced level.
•	Assisted with periodic TMF reviews, document QC process, document approval and final TMF reconciliation.
•	Prepared and presented weekly TMF health metrics for the Internal team and Sponsors;
•	Delivered comprehensive TMF status reports to clinical research associates and trial teams, facilitating cross-functional communication and resolving document discrepancies in a timely manner.
•	 Supported audit preparation and contributed to the inspection readiness by managing document reconciliations and quality checks.
•	Contributed to study start-up and close-out activities, including site initiation, investigator meetings, and archiving processes.
•	Ensured all study documents are archived in the eTMF based on the guidelines and policy (Identified and QC the essential documents, resolved open queries).

Project Specialist

Monroe Carell Jr. Children’s Hospital at Vanderbilt - Department of Pediatrics

Acted as the primary point of contact between the clinical trial sites and the Client pharma team.
•	Coordinated and executed complex biotech and pharmaceutical-sponsored pediatric neurological, genetic, and nephrology clinical studies. 
•	Managed enrollment from screening to randomization, organized site monitoring visits, and maintained accurate data entry in trial management systems (CTMS, eTMF, IXRT lab portal, Trial Master Source and SharePoint, Veeva Vault).
•	Successfully enrolled and retained more than 85% of the patients in the Phase 2- 3 clinical trials.
•	Contributed to the development of all plans and tracking tools used for study management and reporting during start-up, data lock, study closeout
•	Archived study files, CRF review, and record data from source documentation and systems (Epic)

Clinical Translational Research  Coordinator III

Vanderbilt University School of Nursing

Team management and collaborative capabilities:
•	Coordinated complex clinical trials in pediatric neurology and other specialties, managing enrollment, site visits, and clinical data entry within CTMS and eTMF systems.
•	Led a research study team (research assistants and analysts), participated and prepared meeting minutes agenda with action items for internal meetings with PIs.
•	Performed clinical research activities and investigations relating to adult oncology including subject screening and enrollment, data collection, and reporting as per institution requirements.
•	Reduced operational costs by 30% through strategic negotiation and vendor management while ensuring the integrity and quality of clinical data.

Clinical Research Coordinator- Supervisor

•	Served as the primary communication point of contact with principal investigator and assisted in developing plans for research studies and discussed interpretation of results.
•	Assisted in re-evaluation and coordination of research procedures and techniques such as screening in StarPanel, recruiting, interviewing study participants in different clinics (Oncology, Radiation-Oncology & ENT clinics).

Research Analyst III 

As a detail-oriented Senior TMF Associate passionate about maintaining regulatory compliance and ensuring trial documentation accuracy, I bring over 8.5 years of hands-on experience in managing TMF across all stages of clinical research studies. My expertise in leveraging electronic TMF systems and my commitment to GCP and ICH guidelines ensure that projects stay audit-ready and inspection-compliant. With a proactive approach to problem-solving and a collaborative mindset, I thrive in dynamic environments where precision and teamwork are essential for advancing life-changing treatments. I’m driven by a desire to contribute to high-quality, compliant clinical trials that meet regulatory requirements and drive patient safety.

Let's connect to explore collaboration opportunities or discuss how my expertise can contribute to your clinical research initiatives! Open to networking and discussing potential roles in the dynamic field of Clinical Research.

Taplio

Daniela Stoian, MBA's Linkedin Analytics

Want to drive more opportunities from LinkedIn?

Taplio

.css-1jgreyo{background-image:linear-gradient(284deg, rgba(39,43,72,1) 0%, rgba(33,47,183,1) 100%);color:transparent;-webkit-background-clip:text;background-clip:text;}Daniela Stoian, MBA's Linkedin Analytics

Want to drive more opportunities from LinkedIn?

Daniela Stoian, MBA's Linkedin Analytics