Associate Country Study Manager – CV

AstraZeneca

. Serve as Study Delivery Team Lead (SDTL) and Local Study Team Lead (LSTL) .

Posted 11/5/2026full-timeBeijing • ChinaMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study delivery, including planning, execution, and compliance with ICH-GCP and local regulations. Proven ability to lead study teams, manage budgets, and ensure successful recruitment and operational efficiency.

Highest-signal resume keywords

Clinical Study DeliveryICH-GCP ComplianceStudy Team LeadershipBudget ManagementRegulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsStudy SpecificationsFeasibility AssessmentsMonitoring PlansSAE ReconciliationDocument TranslationStudy Master File ManagementRecruitment StrategiesOperational DocumentsTraining Preparation

Soft Skills

Excellent CommunicationAdaptabilityCoachingTeam ManagementProblem Solving

Tools & Technologies

IMPACTIT Systems

Industry Keywords

Clinical OperationsR&DAZ Procedural DocumentsLocal RegulationsStudy Closeout

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Serve as Study Delivery Team Lead (SDTL) and Local Study Team Lead (LSTL)
Plan and lead clinical study delivery from Study Specifications through closeout and Clinical Study Report activities
Form and manage study teams, resources, timelines, budgets, materials, feasibility assessments, and recruitment strategies
Prepare and deliver clinical study protocols, amendments, operational documents, submissions, reports, and training
Participate in steering committees, submission assembly teams, regulatory defense teams, advisory boards, audits, and inspections
Select and negotiate with external service providers and manage contingency risk plans
Lead local study teams, monitors, and study administrators at country level
Ensure compliance with AZ procedures, ICH-GCP, local regulations, and study commitments
Develop local monitoring plans, review monitoring reports, conduct co-monitoring and QC visits, and resolve study issues
Coordinate investigator selection, investigator meetings, recruitment communications, and national investigator relationships
Forecast study timelines, resources, recruitment, budget, study materials, and drug consumption
Manage country SMA, fSMA, Master CSA, Study Master File completeness, SAE reconciliation, document translation, EC/IRB and regulatory submissions
Set up and maintain country studies in IMPACT, ensure study payments, and prepare documents for archiving
Coach and train Local Study Team members and support competency development
Report study progress, milestones, key issues, and monitor/CRA performance to Line Managers

Requirements

What you’ll need

University degree and/or equivalent in biological science or a healthcare-related field
Minimum 5 years’ experience in R&D Clinical Operations or related fields
At least 1 year working as LSTL
Excellent knowledge of spoken and written English
Good ability to learn and adapt to work with IT systems
Right to work in the country where the role is advertised
Knowledge and compliance with ICH-GCP, AZ Procedural Documents, and local regulations

Benefits

Comp & perks

AstraZeneca equal opportunity and diversity commitments
Employment eligibility and work authorization compliance