General 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
Essential Functions of the Job: - 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
Supervisory Responsibilities: 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
Computer Skills: - Proficient in Microsoft Office - Outlook, Word, Excel, PowerPoint, Teams
Other Qualifications: - Knowledge in the execution of clinical trials, understanding of ICH/GCP
- Effective prioritization in the achievement of goals
- Strong written and verbal communication skills
- Highly organized
- Diligence in follow through
- Two years of management experience
- Line management experience
- Functional Service Provider model knowledge and/or experience
- Mentoring and training team members
Travel: Up to 10%
Education/ Experience Required: - Bachelor's degree or higher in a scientific or healthcare discipline preferred.
- Minimum of 5 years progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment
Salary Range: $118,600.00 - $158,600.00 annually
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.
