Study Start-Up Manager

BeiGene

3d•$118,600 - $158,600•Hybrid

About The Position

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.

Requirements

Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams
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
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

Nice To Haves

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

Responsibilities

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
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