Senior Specialist, Global Trial Master File

BeiGene; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

BeiGene, a rapidly growing biotech company, seeks a TMF Operations Manager to oversee TMF quality and compliance for clinical studies. The successful candidate will lead TMF management processes, ensuring timely documentation and inspection readiness. Candidates should possess strong communication, organizational, and problem-solving skills along with relevant experience in a clinical research environment.

Qualifications

• 3-4 years' experience in a clinical research environment is required.
• Trained in regulatory requirements including ICH and GCP.
• Excellent communication and organizational skills are crucial.

Responsibilities

• Manage TMF quality and compliance throughout studies.
• Ensure TMF documentation is submitted timely and accurately.
• Provide monthly TMF metric reports to project team.

Skills

Communication

Organizational skills

Problem Solving

Education

3-4 years' experience in clinical research environment

Trained in clinical research regulatory requirements

Tools

Microsoft Office Suite

Veeva Clinical Vault (eTMF)

Job description

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 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).

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

We are proud to be an equal opportunity employer and we value diversity. 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.