[Hiring] Study Start-Up Manager @BeiGene

Role Description

Clinical Operations leadership role with project responsibilities and accountability in the delivery of Study Start-Up (SSU), initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, SOPs, and local regulations.

• Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards.
• Monitors start-up metrics and compliance with CTMS business rules and global eTMF standards.
• Responsible for managing and addressing SSU performance.
• Actively drives best practices and process improvement to optimize efficiencies in delivery.
• Leads team in achievement of study, departmental, and organizational goals by providing guidance, support, and development opportunities.

Qualifications

• Demonstrates mastery of skills required to conduct SSU activities from selection through activation.
• Manage SSU resource allocations and conduct ongoing assessments to ensure balanced workload for quality delivery.
• Provide country-specific SSU expertise to project teams.
• Assignment as SSU Lead, providing back-up support as needed for direct reports’ studies.
• Competent in communication and influencing skills to ensure timely follow-up, risk mitigation, issue resolution, and updates to teams.
• Manage and maintain local SSU tools and resources.
• Familiar with ICF GCP, relevant country regulations/guidelines, and SOPs.
• Facilitate SSU Forum discussions.
• Support in resource forecasting activities.
• Contribute to the development of local workflows to streamline output and deliverables.

Requirements

• Line Management.
• Interview and onboard new hires; ensure ongoing training compliance.
• Conduct regular 1:1s to assess workload, provide guidance and feedback, develop team.
• Conduct mid-year and year-end performance check-ins and reviews.

Benefits

• Salary Range: $118,600.00 - $158,600.00 annually.
• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan.
• Commercial roles are eligible to participate in an incentive compensation plan.

Company Description

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.

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].