Regional Clinical Study Manager

beigene; Malaysia; On-site; MYR 120,000 - 160,000; Full time

Job summary

BeOne in Malaysia is seeking a senior regional clinical operations leader responsible for delivery of regional studies, leadership of the regional operations team, and collaboration with external partners. You will drive timelines, ensure inspection readiness, and align regional goals with global study plans.

A track record in regional study management and regulatory compliance is required. This role offers challenging opportunities to shape trials across indications while coordinating with CSTs

Qualifications

• Experience leading regional clinical operations for multicenter studies.
• Strong knowledge of regulatory requirements and ICH/GCP guidelines.
• Excellent cross-functional and vendor-management abilities.

Responsibilities

• Leads the regional clinical operations team and acts as escalation point for regional issues.
• Oversees external vendors delivering studies at regional level.
• Provides regular regional study progress updates to senior management.
• Represents the regional study team at CST meetings and internal forums.
• Drives regional trial start-up, recruitment timelines and country allocations.
• Ensures regional compliance with ICH/GCP and regulatory requirements.
• Collaborates with CST and site teams to ensure study readiness.

Job description

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

General Description:

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
• Acts as regional lead for multiple studies across an indication or across a program as required
• Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
• Ensures alignment of regional deliverables with overall study goals
• Contributes to the development of regional tools and leads the development of work instructions and SOPs as required

Essential Functions of the job:

Regional Leadership

• Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study
• Leads external vendors involved in study delivery on a regional level
• Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
• Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings
• Leads regional operations meetings with all regional study team members
• Displays therapeutic area knowledge and expertise

Timelines, Planning and Execution

• Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
• Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these
• Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
• Provides regional input on global study plans as required
• Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs
• Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs
• Ensures regional and country information in study systems and tools is 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 and QC'd on a regular basis as per the study TMF QC plan
• Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status 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, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing

Quality:

• Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads
• Monitors study activities in region to ensure compliance with 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
• Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented
• Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
• Collaborates with CST members and othercolleagues to ensure cross-team, s