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BeiGene
United States · remote · USD 136400-181400 annual
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.
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
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
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
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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
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, 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
Leads the development, optimization and review of work instructions and SOPs as required
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 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
Mentors junior team members and might take on line management responsibilities as required
6 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
Travel might be required as per business need
Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred
*exceptions might be made for candidates with relevant clinical operations experience
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas