Pratima Tharval
Boston,MA
Summary
Experienced Trial Master File (TMF) Professional with a strong background in clinical trial documentation, regulatory compliance, and audit readiness. Passionate about ensuring TMF integrity and inspection readiness by collaborating with cross-functional teams and streamlining processes. Skilled in eTMF systems, data management, and quality control, with a keen eye for detail and efficiency. Dedicated to supporting clinical teams, mentoring colleagues, and driving improvements that make trial documentation smoother and more transparent. Known for problem-solving, adaptability, and a proactive approach to managing multiple projects in a fast-paced environment.
Overview
2025
2025
years of professional experience
1
1
Certification
Work History
Trial Master File Process Specialist
Alexion, AstraZeneca Rare Disease
06.2022 - Current
- Oversee and maintain TMF processes, ensuring compliance with AZ SOPs, ICH-GCP, EMA, FDA, and global health authority guidelines
- Provide guidance on TMF best practices, supporting ongoing and ad-hoc projects to drive continuous improvement in TMF operations
- Manage study creation, maintenance, and archival, ensuring audit readiness and regulatory compliance across multiple projects
- Lead portfolio-level TMF initiatives, collaborating with CROs and internal teams to implement process changes and ensure seamless integration
- Track KPIs and metrics, generating reports and working closely with Clinical Trial Managers and Project Leads to ensure study progress
- Develop Veeva Vault dashboards to improve TMF metrics visibility for the TMF Steering Committee, enhancing decision-making and data transparency
Associate Document Specialist
Unicon Sciences: Karyopharm Therapeutics
02.2020 - 05.2022
- Ensured TMF quality, compliance (ALCOA+C, GCP, EMA, FDA), and inspection readiness through audits, reconciliations, and metric tracking
- Managed TMF queries, collaborated with cross-functional teams, and acted as SME for eTMF systems to ensure document accuracy and completeness
- Led TMF training, mentorship, and interviews, developing materials and enhancing team competency in document management
- Supported Clinical Project Managers and Inspection Readiness Teams in tracking TMF milestones, document reviews, and regulatory submissions
- Managed multiple TMF projects, streamlined workflows, and prioritized tasks to meet stringent deadlines in a fast-paced environment
- Led training on Audit Modules in TI V10.1, developed project roadmaps aligned with DIA Reference Model V3.1, and supported TMF reconciliation for EMA inspections
Graduate Assistant
Long Island University
01.2016 - 12.2017
- Provided support for faculty and students with computer software and hardware, troubleshooting and resolving technical issues
- Coordinated meetings and administrative tasks for faculty, including scheduling, agenda preparation, and distributing minutes
- Assisted in staff training sessions by handling logistics, preparing materials, and ensuring smooth execution
Freelance Counselor for Baby Care & Parenting
05.2008 - 07.2012
- Provided prenatal and postnatal care support to mothers, promoting breastfeeding awareness and offering guidance on pregnancy-related changes
- Supported emotionally disturbed children/adolescents through role modeling, medication monitoring, and distribution
- Conducted educational lectures on the journey to motherhood, addressing key changes during pregnancy and offering guidance to new mothers
Medical Coder
Health Prime International
- Worked as a medical coder, applying codes and ensuring accurate billing and practice management
- Tracked and applied payments to patient accounts, ensuring timely reimbursements and balancing daily batches
- Analyzed codes and reported underpayments, using insurance fee schedules to ensure correct billing
- Collaborated with insurance companies to verify patient information and resolve discrepancies
Well-being Advisor
Goldshield Healthcare Private Ltd
- Conducted health assessments and provided one-on-one advice to individuals, offering referrals to appropriate services as needed
- Advised on diet and lifestyle changes based on health assessment results, promoting healthier living
- Created awareness for the adoption of healthy lifestyle choices through outreach and personalized guidance
Medical Internship
Bharati Vidyapeeth Homoeopathic Hospital
- Worked as an attending physician, responsible for taking detailed patient histories, performing physical examinations, and following up on patient care
- Assisted in C-sections and provided counseling and psychological assistance to patients before and after surgery
- Conducted various diagnostic and treatment healthcare camps and awareness programs in rural villages for women and infants
Education
Master's in Public Administration - Healthcare Administration
LIU POST
Brookville, NY12.2017
Bachelor of Homoeopathic Medicine & Surgery - undefined
Bharati Vidyapeeth Homoeopathic Medical College
06.2004
Skills
- TMF Management & Compliance
- ETMF Systems (Veeva Vault, Trial Interactive)
- Regulatory & Inspection Readiness (ICH-GCP, EMA, FDA)
- Clinical Trial Documentation & Audits
- KPI & Metrics Tracking
- Process Improvement & Best Practices
- Cross-functional Collaboration & Training
- Data Management & Quality Control
- Project Management & Leadership
- Problem-Solving & Adaptability
Certification
- Certificate in Gynecology & Obstetrics, Wadia Hospital, 2006
- Certificate in Child Health Care, Wadia Hospital, 2006
Timeline
Trial Master File Process Specialist
Alexion, AstraZeneca Rare Disease
06.2022 - Current
Associate Document Specialist
Unicon Sciences: Karyopharm Therapeutics
02.2020 - 05.2022
Graduate Assistant
Long Island University
01.2016 - 12.2017
Freelance Counselor for Baby Care & Parenting
05.2008 - 07.2012
Well-being Advisor
Goldshield Healthcare Private Ltd
Medical Internship
Bharati Vidyapeeth Homoeopathic Hospital
Bachelor of Homoeopathic Medicine & Surgery - undefined
Bharati Vidyapeeth Homoeopathic Medical College
Medical Coder
Health Prime International
Master's in Public Administration - Healthcare Administration
LIU POST
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