Senior Specialist, Global Trial Master File

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description :

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.

Essential Functions of the job :

• 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 to maintain inspection and audit readiness.
• Generates and provides monthly TMF metrics Reports to the Project Team / leadership team.
• Leads the TMF maintenance (EDL updates and milestones) in the eTMF system.
• Performs assigned complex administrative tasks to support team members and other related tasks as assigned.
• Oversees filing accuracy and compliance with BeiGene guidance, project plan, and SOPs where applicable.
• Oversees or performs study TMF review and checks the compliance of study TMF content / completeness.
• Establishes and maintains effective internal and external client communications.
• Serves as primary contact for internal / external clients.
• Optimizes Clinical Operations TMF management processes and offers solutions.

Education Required :

• 3-4 years' experience working in relevant clinical research environment. Equivalent combination of education, training, and experience is preferred.
• Trained in clinical research regulatory requirements, e.g., ICH, 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.
• Proficient in computer technology and software programs, with 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 Microsoft Office Suite. Knowledge of and ability in Veeva Clinical Vault (eTMF).

Additional skills and attributes are detailed, emphasizing ethics, planning, communication, teamwork, adaptability, technical skills, dependability, quality, analytical skills, problem-solving, and project management, aligning with BeiGene's core values.

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