Regional Clinical Study Manager/Senior Manager

Beigene; Nouvelle-Zélande; Sur place; NZD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Market competitive compensation

Company shares

In-house and external learning and dev

Benefits program

Résumé du poste

BeOne seeks a Regional Clinical Study Manager/Senior Manager in New Zealand to oversee regional delivery of clinical studies, ensuring inspection readiness, quality, timelines, and budget adherence.

You will lead the regional clinical operations team, including external partners, and serve as escalation point for issues within the region. Collaboration with stakeholders and CST is essential to align regional and global study goals.

Qualifications

• 4+ years of progressive experience in clinical research within biotech, pharma or CRO.
• Experience leading regional clinical operations and coordinating with external partners.
• Knowledge of regulatory processes and study startup activities.

Responsabilités

• Lead the regional clinical operations team and external vendors.
• Ensure alignment of regional deliverables with global study goals.
• Drive feasibility, site selection, and regional regulatory submissions.
• Provide regular updates to senior management and CST as required.

Connaissances

Leadership

Stakeholder management

Vendor management

Clinical operations

Data analysis

Formation

Bachelor’s Degree in scientific or healthcare discipline

Higher Degree preferred

Outils

MS Office

Project Planning Applications

Description du poste

Accountable for regional study delivery with appropriateinspection readinessquality, within agreed timelines and budget

Leads theregional clinical operationsteam(including oversight of external partners working on the regional level)and acts as point of escalation for resolution of issues withinthe region for the assignedstudy

Ensures alignment ofregional deliverables with overallstudy goals

Essential Functions of the job:

Regional Leadership

Leadstheregional clinical operations teameffectively,ensures effective decision making andacts as point of escalation for resolution ofissues within the region for the assignedstudy

Leads external vendors involved in study delivery on a regional level

Collaborates withkeystakeholdersin the regionand provides regular updates on study progressin the regionto senior managementandGlobal Clinical Study Manageras required

Represents theregionalstudy team at internal meetings andatthe cross-functional Clinical Study Team(CST)meetings

Leads regional operations meetings with all regional study team members

Timelines, Planning and Execution

Leads planning and management of the assigned clinical study(ies) fromfeasibilitythrough closeout activities for region, in line with global study timelines

Generates, manages, and maintains high qualitystudy startup andrecruitmenttimelinesfor regionand tracks progress towards these

Ensures that the clinicalstudy isoperationally feasiblein the region,drivestrial feasibility, country allocationand site selection processfor assigned region in collaboration withfeasibility managers, country heads, medical affairs and any other stakeholders

Provides regional input on global study plans as required

Ensures timely availability oflocal adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holdersto ensure timely submission to regulatory authorities and ECs/IRBs

Accountable for submissions of study in countries in assigned regionin close collaboration withregionalstudy start upteamand regulatory affairs

Ensuresregional and country information in studysystems and toolsis entered and up to date

Collaborates closely with CRAs in the region to ensure proper study execution at the sites.Reviews and signs-off monitoring reports

Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained andQC’don a regular basisas per the study TMF QC plan

Provides input to Global Clinical Suppliesregarding drug inventories in regionand reviews local drug labels for region.Provides input on localregulatoryapprovaland reimbursementstatus of comparator drugs used in study for countries in region

Manages the trial data collection process for the region, drives data entry and query resolution

As required, supportsplanning and execution of the Clinical Study Report in collaboration withGlobal Clinical Study Manager and Medical Writing

Quality:

Handles escalatedissuesor problemswith the sitesin region in close collaboration with stakeholders such as country heads

Monitors study activities in region to ensure compliance withthe study protocol,SOPs, ICH/GCP and all other relevant regulations

Ensures inspection readiness for study in region at any point in time throughout the study life cycle

InformsGlobal Clinical Study Managerof any issues arisingon the study, evaluates impact and ensuressolutions are implemented

Prepares sites for quality assurance audits and inspections, drivesresponses to audit and inspection findings as appropriate

Collaborates withCST members andcolleagues to ensure cross-team, site learnings, and best practices are shared

Leads improvements and partners withCSTmembers to enhance the efficiency and the quality of the work performed on assigned studies

Contributes to development, optimizationand review of work instructions and SOPs as required

Budget and Resources

Works with the sourcing team to select and manage regional study vendors

Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities

Identifies and managesregionalteam resource needs and establishes contingency plans for key resources

Monitors regional resource utilization over study lifecyleand liaises with functional managers as needed

Supervisory Responsibilities:

Provides performance feedback on team members as required

Might mentorjunior team members

Qualification Required:

Education Required:

Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred

Computer Skills:

MS Office, Project Planning Applications

Other Qualifications:

4or more years of progressive experience in clinical research within biotech, pharma or CRO industry

Provenexperience in clinical researchincluding relevant experience as team lead inclinicialfunctions

Experience as CRA is preferred

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Acts Inclusively
• Demonstrates Initiative
• Results-Oriented
• Analytical Thinking/Data Analysis
• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job

Regional Clinical Study Manager/Senior Manager • New Zealand