Associate Director, Regional Clinical Study Management

BeOne Medicines

. Accountable for regional study or portfolio delivery with inspection-readiness quality, within agreed timelines and budget .

Posted 10/2/2026full-timeRemote • United StatesSenior💰 $143,300 - $193,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading regional clinical operations, ensuring compliance with ICH/GCP regulations, and managing study budgets and timelines. Proficient in developing regional tools and SOPs while mentoring team members to enhance operational efficiency.

Highest-signal resume keywords

Clinical Operations ManagementRegulatory Compliance (ICH/GCP)Study Budget ManagementTeam Leadership and MentoringProject Planning Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementData Collection and Query ResolutionTrial Master File MaintenanceStudy Start-Up and Recruitment TimelinesFeasibility AssessmentSOP DevelopmentRisk Identification and MitigationVendor ManagementBudget NegotiationRegulatory Submission Coordination

Soft Skills

Strong Communication SkillsInterpersonal SkillsOrganizational SkillsJudgment and DiscretionAbility to Influence

Tools & Technologies

MS OfficeProject Planning Applications

Industry Keywords

BiotechPharmaceuticalCROClinical TrialsInspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for regional study or portfolio delivery with inspection-readiness quality, within agreed timelines and budget
Act as regional lead for one or multiple studies across an indication or program
Lead the regional clinical operations team, including external regional partners
Serve as point of escalation for regional study or portfolio issues
Develop regional tools, work instructions, and SOPs
Drive regional trial and portfolio deliverables
Lead planning and management of assigned clinical studies from feasibility through closeout
Generate and maintain regional study start-up and recruitment timelines
Drive regional trial feasibility, country allocation, and site selection
Provide regional input on global study plans
Coordinate local adaptations of global study documents and regulatory/EC/IRB submissions
Ensure regional and country information in study systems and tools is current
Coach and mentor CRAs; review and sign off monitoring reports as needed
Ensure country and site-level Trial Master File creation, maintenance, and quality control
Provide input on regional drug inventories, local drug labels, comparator drug regulatory approval, and reimbursement status
Manage regional data collection, data entry, and query resolution
Support Clinical Study Report planning and execution
Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations
Maintain inspection readiness and prepare sites for audits and inspections
Identify regional risks, implement solutions, and share best practices
Lead improvements to study efficiency and quality
Select and manage regional study vendors
Manage and negotiate regional study budgets
Coordinate investigator fees, site payments, and patient travel reimbursement
Monitor regional resource utilization
Ensure clinical team competencies meet company requirements
Mentor junior team members and support development plans

Requirements

What you’ll need

Bachelor's degree in a scientific or healthcare discipline
8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
Preferably master's degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
Proficiency with MS Office and project planning applications
Solid leadership and management experience either as a direct line manager or cross-functional team lead
Strong written and verbal communication skills
Sound judgment and discretion in matters of significance
Ability to work independently and effectively handle multiple priorities in a fast-paced environment
Excellent interpersonal and organizational skills
Ability to influence and lead
Willingness to travel as required by business need

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness benefits
Reasonable accommodation in the job application process