Summary
Overview
Work History
Education
Skills
Accomplishments
Software
Certification
Timeline
Generic
Marhaini Mohar

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
04.2021 - 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
04.2001 -

Skills

Customer relations

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

Veeva eTMF

Microsoft

Power BI

Certification

ICH-GCP Certification, Syneos Health

Timeline

ICH-GCP Certification, Syneos Health

01-2025

Audit Preparation Training

01-2025

Integrated Quality Risk Management (IQRM) Process and Risk Based Monitoring (RBM) Model ((SH) IQRM212)

01-2025

GenAI Fundamentals, (SH) GENAI0001

01-2025

Trial Master File Specialist

Syneos Health
04.2021 - Current

Bachelor of Science - Industrial Physics

University Of Technology Malaysia
04.2001 -

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Marhaini MoharTrial Master Specialist