Associate/regional Clinical Study Manager

3 days ago

Sydney, Australia BeiGene Full time

Employee

Full time

About the Company:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

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 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 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

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