Study Start-Up Manager

BeOne Medicines

Clinical Operations leadership role at BeOne delivering Study Start-Up (SSU) responsibilities and ensuring high-quality clinical trial activities. Managing SSU performance towards project goals within established timelines.

Posted 6/12/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $118,600 - $158,600 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
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
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

Requirements

What you’ll need

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
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

Benefits

Comp & perks

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial executionStudy Start-Up (SSU)project managementresource allocationperformance managementprocess improvementworkflow developmentrisk mitigationcompliance monitoringCTMS

Soft Skills

communication skillsinfluencing skillsorganizational skillsdiligenceprioritizationteam developmentmentoringtrainingguidancefeedback