BeiGene 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:
Acts as line manager for study start-up and trial monitoring staff (incl CRA line managers as applicable) in UK & Ireland.
Drives the study start-up and trial monitoring team in the UK & Ireland to achieve excellence in study start-up and site monitoring
Partners with both internal (e.g., medical affairs colleagues) as well as external (e.g. clinical sites, Key Opinion Leaders) stakeholders to establish BeiGene as a collaboration partner for clinical trials in the UK
Demonstrates a high level of clinical operations knowledge, organizational skills, project management and leadership competencies
Implements best practices and shares lessons learned with the team and other colleagues as appropriate
Ensures consistency in processes and drives Monitoring Excellence and clinical Operations performance in the UK & Ireland
Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
Works to high quality and maintains a positive and results-orientated work environment.
Essential Functions of the Job:
Responsible for building and developing the start-up and trial monitoring team in the UK & Ireland, including the hiring, training, development and resource allocation of BeiGene staff and oversight of FSP staff in the UK & Ireland
Builds partnerships with FSP vendors to allow optimal resource utilization in both study start-up and site monitoring teams in the UK & Ireland
Oversight of study start-up and monitoring in the UK & Ireland to:
achieve timely and complete IRB/EC submissions
ensure TMF completeness prior to handover from Start-Up to the Monitoring team
ensure successful delivery of country site commitments, i.e., achieving site activation and enrolment goals within planned timelines, as well as maintaining inspection readiness
Performs accompanied visits of CRAs to assess their performance
Builds knowledge of clinical site capabilities in the UK & Ireland to optimize site selection
Establishes effective site relationships with key sites in the UK & Ireland to optimize timelines, recruitment, quality and overall performance
Collaborates with other Clinical Operations functions (e.g., Trial Management) to support the successful planning and execution of clinical trials
Collaborates with other line functions (e.g., Medical Affairs, Commercial, New Markets) to support site relationships and build a strong presence of BeiGene.
Collaborate with other countries to support process improvement, knowledge sharing and teamwork.
Provides ongoing mentoring and training to study start-up and trial monitoring teams and other functional areas as needed on Monitoring Excellence tools and planning
Assists in maintaining and updating company-level investigator database
Leads initiatives and workstreams within Monitoring Excellence, as required
Provides input into SOP development that impact on Monitoring Excellence
Contributes to Clinical Operations strategy and performance against key metrics
Supervisory Responsibilities:
Ensure the competencies and skills required for study start-up and trial monitoring team in the UK & Ireland are consistent with the company-defined requirements.
Conduct mid-year and year end performance appraisals for direct reports, which include providing constructive feedback as well as oversight of subordinate team’s performance.
Education Required:
Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
Other Qualifications:
10 years+ progressive experience in clinical operations, preferably within the biotech/ pharmaceutical sector within the UK & Ireland
Solid leadership and management experience, experience in therapeutic area (oncology) is highly recommended
Ability to work independently and effectively handle multiple priorities in a fast-paced environment
Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization
In-depth understanding of the clinical trial landscape (trial sites, regulation, patient flows) in the UK and Ireland
Travel: up to 10-15%
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
BeiGene Global Competencies:
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
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