Project Manager, Global Trial Master File Management & Records

BeiGene 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:

Project Manager, Global TMF is a pivotal role responsible for driving the timely and successful execution of strategic projects and change initiatives across the Global TMF Management & Records department through the effective use of project management skills. With expertise in clinical systems, such as Veeva Vault eTMF and others, and cross-functional IT project management, the Project Manager oversees the team’s portfolio, ensuring seamless collaboration between Global TMF Team, GCO teams, GTS/IT and other stakeholders. They drive global, complex projects, ensuring compliance with GxP systems and processes, while navigating a fast-paced multinational environment with cross-cultural acumen and effective communication skills.

Essential Functions of the job: 

• Leads prioritization and management of the team’s diverse project portfolio.

• Manages the entire project lifecycle, from request through delivery, ensuring seamless execution.

• Liaises and collaborates as required with external, global, and/or regional stakeholders such as vendors, Global Tech Solutions (GTS), and Global Clinical Operations leaders. Ensures team readiness and support for project commitments.

• Works with stakeholders from various departments on the development of requirements and standards.

• Provides vendor oversight to ensure project delivery is on time and within budget.

• Supports the development of business process documentation, including Standard Operating Procedures (SOPs).

• Direct experience leading Organizational Change Management (OCM) efforts and developing communication and change-related content.

• Experience in developing organizational metrics and key performance indicators.
   

Quality

• Ensures team members are trained in and are adhering to required processes and SOPs.

• Supports the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.

Supervisory Responsibilities:   

• Manages contractors and their workload/assignments.

Project and Program Management

• 5+ years’ experience deploying applications and/or systems with a focus on Clinical systems in a biotech, pharmaceutical industry.

• Project Management Professional (PMP) Certification preferred.

Computer Skills:     

• Must be highly proficient with business standard project management applications (e.g., Smartsheet, MS Project), flowchart applications (e.g., MS Visio), MS Office Suite (Word, Excel, PowerPoint), and collaboration tools (e.g., Office 365, Zoom).

• Proven experience in planning and delivery of clinical system solutions.
   

Education/Experience Required: Bachelor's degree in life sciences, business, or related field preferred or equivalent combination of education and experience of 5+ years of progressive experience in clinical systems within biotech, pharmaceutical or CRO industry.

Other Qualifications:   

• Manages multiple Global TMF projects and its project lifecycle, from request through delivery, ensuring seamless execution.

• Ability to lead, influence, collaborate and negotiate to achieve business strategies, drive accountability, and deliver results.

• Effective communication skills, including the ability to articulate results and recommendations of analysis to a variety of audiences within the organization (e.g., laterally across peers, and upward to Senior Management).

• Experience with core biotech/pharmaceutical software applications, eTMF, CTMS, and other Clinical systems.

• Ability to effectively adapt, prioritize and execute tasks in a high-pressure and agile environment through analytical and problem-solving capabilities.

• Demonstrated knowledge of SDLC methodologies such as Waterfall, Lean, or Agile.

• Experience working in GxP validated environment.

• Excellent written and oral communication skills.

• Highly organized, self-motivated and directed.

Travel:   

• Required as per business need.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.