Regional Clinical Study Manager/Senior Manager

About us BeiGene 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 BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter). Job Description: General Description of the Job: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget.
Leads the regional clinical operations team (including oversight of external partners working on the 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.
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.
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 stakeholders 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 the 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 colleagues to ensure cross-team, site learnings, and best practices are shared.
Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies.
Contributes to development, optimization and review of work instructions and SOPs as required.
Budget and Resources: Works with the sourcing team to select and manage regional study vendors.
Manages regional study budgets.
Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities.
Identifies and manages regional team resource needs and establishes contingency plans for key resources.
Monitors regional resource utilization over study life cycle and liaises with functional managers as needed.
Supervisory Responsibilities: Provides performance feedback on team members as required.
Might mentor junior team members.
Qualification Required: Bachelor's Degree in a scientific or healthcare discipline required, Higher Degree preferred.
4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
Proven experience in clinical research including relevant experience as team lead in clinical functions.
Experience as CRA is preferred.
Excellent communication and interpersonal skills.
Excellent organizational skills and ability to prioritize and multi-task.
Fluent in English (writing and speaking).
Efficient in Microsoft Word, Excel, and Outlook.
Travel might be required as per business need.
Full working rights in Australia (Citizen or PR).
What we offer to our valued employees: Market competitive compensation package including performance-based annual bonus scheme.
Company shares (generous welcome grant and performance-based annual equity plan
).
Full-time working from home (with an option to work from the Sydney office).
In-house and external learning and development opportunities.
Fantastic benefits program as per the current policy including:
Personal health insurance reimbursement.
Home-office setup allowance.
Monthly reimbursement for home office expenses (i.e.
internet, mobile).
Group life insurance & income protection insurance.
Wellness benefits (Employee Assistance Program).
Paid parental leave.
And more as the benefit programs are keep improving
Plus you get to work with a dynamic team of collaborative, supportive, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity.
BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
All employment is decided on the basis of qualifications, merit, and business need.
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