SENIOR SPECIALIST, GLOBAL TRIAL MASTER FILE

Responsible for managing all TMF operations and is accountable for TMF quality, inspection readiness, and compliance. Provides Trial Master File (TMF) related assistance to study teams. Involved in TMF management process generation and optimization, including but not limited to the draft and creation of the TMF Management Plan and Index. Ensures all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, GCP, applicable regulatory requirements, and meets quality and timeline metrics.

• Leads the development of the TMF Plan and TMF Index , throughout the study
• Collaborates with the Project Lead (COM / ACOM) and Functional Leads (FL) to ensure TMF documentation is submitted / published in a timely manner and with high quality in order to maintain the TMF in an inspection and audit readiness state.
• Generate and provides monthly TMF matric Reports to the Project Team / leadership team.
• Lead the TMF maintenance (EDL updates and milestones) in the eTMF system
• Perform assigned complex administrative tasks to support team members, and other related tasks assigned.
• Oversight the filing accuracy and compliance to BeiGene, guidance, project plan and Standard Operating Procedures (SOPs) where applicable.
• Oversight or perform study TMF review and check the compliance of study TMF content / completeness check.
• Establish and maintain effective internal and external client communications.
• Serve as primary contact for internal / external clients.
• Optimize Clinical Operations TMF management processes and offer solutions
• Education Required :
• 3-4 years' experience working in relevant clinical research environment. Equivalent combination of education, training and experience are preferred.
• Trained in clinical research regulatory requirements. i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines.
• Other Qualifications :
• Excellent oral and written communication skills
• Ability to establish and maintain effective working relationships with internal and external clients.
• Trained in computer technology and software programs, and accurate data entry skills.
• Trained in technology applications relevant to records center environments.
• Strong organizational, planning, and decision-making skills.
• Ability to manage and lead others.
• Good problem-solving skills.
• Fluent in spoken and written English
• Computer Skills :
• Proficient in the use of the Microsoft Office Suite. Knowledge of and demonstrated ability in Veeva Clinical Vault (eTMF).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.