[Hiring] Senior Specialist, Global Trial Master File @BeiGene

Role Description

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.

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 in order to maintain the TMF in an inspection and audit readiness state.
• Generates and provides monthly TMF matrix 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 assigned.
• Oversights the filing accuracy and compliance to BeOne, guidance, project plan and Standard Operating Procedures (SOPs) where applicable.
• Oversights or performs study TMF review and checks the compliance of study TMF content/completeness check.
• 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.

Qualifications

• 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.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$83,800.00 - $118,800.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The Company has a comprehensive benefits package that includes opportunities for stock ownership and participation in annual bonus plans.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by relevant laws, applicants who require reasonable accommodation in the job application process may contact [email protected].