Note: The job is a remote job and is open to candidates in USA. BeOne Medicines USA, Inc. is a rapidly growing company focused on fighting cancer. They are seeking a Regional Clinical Study Associate Manager to oversee regional study delivery, manage clinical operations teams, and ensure alignment with overall study goals.
Responsibilities
- Accountable for regional study delivery or specific aspects hereof with appropriate inspection readiness quality, within agreed timelines and budget
- Manages the regional clinical operations team (incl 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, or supports the Regional Clinical Study (Sr) Manager with specific aspects of regional study delivery
- Ensures alignment of regional deliverables with overall study goals
- Manages planning and management of the assigned clinical study(ies) or specific activities 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, manages 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 the 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
- 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 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
- 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 cyle and liaises with functional managers as needed
- Provides performance feedback on team members as required
Skills
- Bachelor's Degree in a scientific or healthcare discipline required
- Higher Degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
Benefits
- Annual bonus plan (Non-Commercial roles)
- Incentive compensation plan (Commercial roles)
- All employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
- Voluntarily participate in the Employee Stock Purchase Plan
- Comprehensive benefits package that includes Medical
- Comprehensive benefits package that includes Dental
- Comprehensive benefits package that includes Vision
- Comprehensive benefits package that includes 401(k)
- Comprehensive benefits package that includes FSA/HSA
- Comprehensive benefits package that includes Life Insurance
- Comprehensive benefits package that includes Paid Time Off
- Comprehensive benefits package that includes Wellness
Company Overview
Company H1B Sponsorship