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 andlogisticsfor cross-functionalClinical StudyTeam (CST) meetings
- Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial ManagementAssociatesand other key stakeholders globally and regionally
- Knowledgeable of clinicalstudyoperations, including interpretation and implementation ofregulatory and ICH-GCPguidelines
- Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager
Planning andExecution
- Creates andmaintainsstudy-levelSharePoint andCSTdistribution lists
- Sets up the study in theappropriate systemse.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 ofvariousstudy plans
- Organizes study-specific investigator meetings under supervision of theGlobal Clinical Study Manager
- Might support the creationand review ofsite feasibility assessmentsrequiredfor study participation
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, dataflowand protocol deviationsin relevant systems in collaboration with Regional Clinical Trial Management Associates
- Prepares metrics and updates to key deliverables for managementas per information available in relevant systems
- Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g.frequentlyasked questions, lessons learned) in collaboration with the study team
- Supports the TMF specialist with study-level TMF creation and, asrequired,maintainsthe study-level TMF, including regular review and QC of TMF documents as per thestudy TMF QCplan
- 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 theGlobal Clinical Study Managerwith planning and execution of the Clinical Study Report
Quality
- Supports the identification of operational risksand issuesand works with theGlobal Clinical Study Managerto recommend solutions for discussion withappropriate teamleadership
- Learns and shares best practices in clinical operations methodologies,systemsand processes with an emphasis on quality and compliance
- Suggestimprovements to enhanceefficiencyand 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:
Computer Skills:
- Proficiency in MS Office Suite, including Excel, PowerPoint and project etc.
Education/ Experience:
- 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
- Bachelor or higher degree in a scientific or healthcare discipline*, higher degree preferred.
- *exceptions might be made for candidates with relevant clinical operations experience
Travel:
- Limited travel might be required
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 annually
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.
