About the role
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.
General Description:
Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget
Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager
Essential Functions of the Job:
Cross-Functional Leadership Support & Collaboration
Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings
Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally
Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines
Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager
Planning and Execution
Creates and maintains study-level SharePoint and CST distribution lists
Sets up the study in the appropriate systems e.g. eTMF, CTMS etc and makes sure study-level information is kept up to date
Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in the study
Supports the development of various study plans
Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager
Might support the creation and review of site feasibility assessments required for study participation
Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates
Prepares metrics and updates to key deliverables for management as per information available in relevant systems
Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g. frequently asked questions, lessons learned) in collaboration with the study team
Supports the TMF specialist with study-level TMF creation and, as required, maintains the study-level TMF, including regular review and QC of TMF documents as per the study TMF QC plan
Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies
Supports the overall data cleaning activities and contributes to the follow-up of outstanding information
Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report
Quality
Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership
Learns and shares best practices in clinical operations methodologies, systems and processes with an emphasis on quality and compliance
Suggest improvements to enhance efficiency and the quality of the work performed on assigned projects
Budget
Supports selection and set-up of vendors for global outsourced activities
Supports study budget management activities with responsibility for PO setup and payment invoice tracking across all study lifecycles.
Supervisory Responsibilities:
N/A
Computer Skills:
Proficiency in MS Office Suite, including Excel, PowerPoint and project etc.
Other Qualifications:
Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
1 or more years of experience in clinical research within Biotech, Pharma or CRO industry
Travel:
Limited travel might be required
Education Required: Bachelor or higher degree in a scientific or healthcare discipline*, 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.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Salary Range: $72,800.00 - $97,800.00 annuallyBeOne 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