Senior Specialist, Global Trial Master File

BeiGene

1d

About The Position

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. Responsible for managing all Trial Master File (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.

Requirements

• 4 years' experience working in relevant clinical research environment.
• Trained in clinical research regulatory requirements. i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines.

Nice To Haves

• Equivalent combination of education, training and experience are preferred.

Responsibilities

• 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 BeOne, 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

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• discretionary equity awards
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees