Clinical Operations Leader
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.
Position Summary :
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 timelinesGenerates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards theseEnsures 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 stakeholdersProvides regional input on global study plans as requiredEnsures 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 / IRBsAccountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairsEnsures regional and country information in study systems and tools is entered and up to dateCollaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reportsResponsible 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 planProvides 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 regionManages the trial data collection process for the region, drives data entry and query resolutionAs required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical WritingQuality :
Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country headsMonitors study activities in region to ensure compliance with the study protocol, SOPs, ICH / GCP and all other relevant regulationsEnsures inspection readiness for study in region at any point in time throughout the study life cycleInforms Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implementedPrepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriateCollaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are sharedLeads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studiesContributes to development, optimization and review of work instructions and SOPs as requiredBudget and Resources :
Works with the sourcing team to select and manage regional study vendorsManages regional study budgetsWorks closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activitiesIdentifies and manages regional team resource needs and establishes contingency plans for key resourcesMonitors regional resource utilization over study life cycle and liaises with functional managers as neededSupervisory Responsibilities :
Provides performance feedback on team members as requiredMight mentor junior team membersComputer Skills :
MS Office, Project Planning Applications
Other Qualifications :
4 or more years of progressive experience in clinical research within biotech, pharma or CRO industryProven experience in clinical research including relevant experience as team lead in clinicial functionsExperience as CRA is preferredTravel :
Travel might be required as per business need
Education Required :
Bachelor's Degree in a scientific or healthcare discipline required
, Higher Degree preferredexceptions might be made for candidates with relevant clinical operations experienceCompetencies :
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.
Planning / Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Shares expertise with others.
Adaptability Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and within budget.
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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking / Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range : $116,300.00 - $156,300.00 annually