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:
Drives, manages and leads all aspects of clinical study start up, from submission to site activation, Including Substantial amendment/modification activities on more than one study and/or multiple countries within the region.
Accountable for participating country SSU study deliverables and co-ordinates activities at local level, ensuring delivery of SSU according to agreed commitments.
Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans for study start up activities.
Works totally independently, assigned to complex/early phase and Corporate Goal studies.
Demonstrates a high level of knowledge in clinical trials Start-up and/or project management experience (or similar skills) with a high level of understanding of local and regional regulations and clinical trials requirements
Demonstrates a high level of leadership, organizational, time management and communication skills
Delegates and oversees clinical operations tasks to other clinical operations representatives in the team, as appropriate.
Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.
Escalation, point of contact person to next level of study oversight/governance as necessary.
Implements best practices and shares lessons learned with team and other colleagues, as appropriate.
Proactively identifies potential issues and seek improvement. Takes the initiative for issue resolution within and outside Study Start Up team.
Drives study regional SSU metrics and KPIs.
Ensures alignment with the CSM (Clinical Study Manager) team for the regional SSU deliverables with the overall project goals.
Essential Functions of the job:
Independently, leads country SSU teams, to the timely delivery of the clinical start-up component of assigned studies.
Be accountable for high quality and timely delivery of assigned activities, which include, but are not limited to:
Provides regional study start-up expertise to the study team.
Responsible for building regional submission strategies.
Responsible for developing and maintaining baseline start-up timelines and plan for all EU countries and re-projecting as necessary, during the study life cycle.
Responsible for maintenance of SSU activities during trial life cycle.
Maintains close collaboration with the regional study management team in the planning, execution, maintenance of the regional study timelines, country initiation and activation strategy.
Activities related to preparation, coordination, and submission (initial and amendments) to CEC(s), LEC(s), and other review bodies, as applicable, during the trial, life cycle
Accountable for the QC/review on the content of submission packages.
Takes accountability for the QC/review of country/site - master ICF (Informed Consent Forms) adaptations.
Accountable for the coordination of translations for submission and start-up related documents.
Oversight of notifications and communications with CEC(s), LEC(s), and other review bodies, as applicable.
Works closely with relevant study stakeholders to ensure appropriate timely responses to CEC(s), LEC(s), and other review bodies, as applicable.
Collaborates with RA team for coordination of timely HA(s), CEC(s) and LEC(s) submissions as applicable.
Accountable for timely and accurate data entry of all relevant SSU activities in the appropriate systems (i.e. CTMS).
Accountable for ensuring the timely and accurate SSU documents filing, review and QC, in TMF.
Centralizes, captures and shares SSU lessons learned and best practices.
Provide regular updates and inputs regional study team meetings including kick-off meetings.
Lead regional start-up regular meetings with country SSUs, local contract specialists, contract manager, Global Regulatory Lead, local RA Lead, CRAs and any ad hoc attendees as necessary.
Maintains close collaboration with the contract management team to ensure the preparation, negotiation, execution and tracking of site contracts/budgets.
Contributes to the development and review of Clinical Operations/SSU WI/SOPs, process creation/ improvements and Workstreams.
Ensures inspection readiness throughout the life cycle of the study.
Supports and provides the oversight for the SSU team with the preparation of audits, inspections, CAPA’s and Serious Breaches.
Performs other duties as assigned by SSU Management team.
Mentors, supports and trains more junior SSUL’s.
Education Required:
Bachelor’s degree (or equivalent) or higher in a scientific, clinical trial, medical or healthcare discipline* (e.g: Registered Nurse) with minimum of 6 years of experience in clinical operations study start-up or regulatory affairs.
*Exceptions may be made for candidates with appropriate Clinical Operations or Regulatory Affairs experience. Experience in biotech, pharmaceuticals or a related field in the biotech/pharmaceutical industry is essential.
Other Qualifications:
Fluent in written and verbal English
Strong interpersonal skills, can do attitude and problem-solving skills
Able to multi-task and meet compressed timelines
Computer Skills:
Good to advanced knowledge of Microsoft Word, Smartsheet’s, Excel, PowerPoint, SharePoint, and Outlook.
Demonstrates good working knowledge of Clinical Trial Management Systems.
Travel:
Limited business travel expected
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
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. Contributes to building a positive team spirit; 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, 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 budget.
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
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.
United Kingdom
