Senior Specialist, Global Trial Master File

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 oversight of 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 Study Lead 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.
• Oversight of 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 of 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
   

Supervisory Responsibilities:
•             N/A
 

Computer Skills:   

• Proficient in the use of the Microsoft Office Suite.  Knowledge of and demonstrated ability in Veeva Clinical Vault (eTMF).

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

Education/ Experience Required:

• 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.
   

Eligibility Requirement:

• This position is open to U.S.-based candidates only.

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

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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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 Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].