Veeva eTMF
Marhaini Mohar
Trial Master Specialist
Kuala Lumpur,14
Summary
Detail-oriented and experienced Trial Master Specialist with over 4 years in clinical trial management. Expertise in regulatory compliance, Trial Master File (TMF) management, and ensuring audit readiness. Proven track record in maintaining high-quality documentation and supporting clinical trial teams to achieve project milestones. Strong communication and organizational skills, with a commitment to upholding industry standards and best practices.
Overview
4
4
years of professional experience
4
4
Certifications
2
2
Languages
Work History
Trial Master File Specialist
Syneos Health
2021.04 - Current
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Coordinated with IT department to upgrade cybersecurity measures, safeguarding company data.
- Support TMF set-up, maintenance, and closure.
Manage electronic and hard copy document scanning, indexing, and quality reviews. - Ensure document security and compliance.
- Liased with TMF lead, Monitors and project managers to ensure accurate and timely completion of study milestones.
- Manage paper documents, requests, filing, and DCR maintenance. Collaborate with document owners to resolve issues.
- Use power BI for data arrangement and data visualization. Proficient in managing multiple research projects and ensure compliance with regimen.
- Strong knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
Oversight of documents (e.g FDA1572, CVs, FDF, etc). - Participate in audits, inspections, and training.
- Maintain compliance with company and role-specific requirements Proficiency in EDC, Metadata, eTMF, CTMS, and TMF, showcasing adeptness in electronic management.
- Competence in software platforms like Veeva Vault, Metadata, Master Control and POWER BI demonstrating expertise in software utilization.
- Versatility in communication, organization, time management, and analytical capabilities, embodying a multifaceted skill set.
- Proficiency in Microsoft Office applications, adept regulatory acumen, and administrative proficiency, rounding out a comprehensive skill set.
- Utilizing different documentation platforms and software.
Education
Bachelor of Science - Industrial Physics
University Of Technology Malaysia
Skudai, Johor 2001.04 -
Skills
Customer relations
Quality assurance
Team collaboration
Root-cause analysis
Skilled in Veeva Vault management
Experienced with Power BI
Skilled in Microsoft applications
Adaptability and flexibility
Analytical problem-solving
Organizational time strategies
Data-driven insights
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Successfully achieving a 0-2% error rate to uphold Good Clinical and Documentation Practices.
- Recognized as a excellent Primary Resource on multiple studies receiving internal team accolades in Spotlight.
- Proficient in Power Bl and Excel Power Query for data analysis and data-driven decisions.
- Complete Training Courses and Certifications as required by assigned project and roles.
- Providing exceptional quality and execution for both internal and external customers and meeting customer deliverables.
Software
Microsoft
Power BI
Certification
ICH-GCP Certification, Syneos Health
Timeline
ICH-GCP Certification, Syneos Health
2025-01
Audit Preparation Training
2025-01
Integrated Quality Risk Management (IQRM) Process and Risk Based Monitoring (RBM) Model ((SH) IQRM212)
2025-01
GenAI Fundamentals, (SH) GENAI0001
2025-01
Trial Master File Specialist
Syneos Health
2021.04 - Current
Bachelor of Science - Industrial Physics
University Of Technology Malaysia
2001.04 -