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 SSUS, CRAs) in the given country Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development of direct reports.
Participate in selection for hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
Demonstrates a high level of clinical operations knowledge, organisational skills, project management and leadership competencies.
Adheres to ICH/GCP, assure clinical trial protocols are executed at clinical trial sites in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs
Collaborate closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
Supports start-up and provide local expertise.
Essential Functions of the Job:
Responsible for managing study start up and trial monitoring staff in accordance with Beigene’s policies and applicable regulations.
Participate in the selection for hiring new employees. Ensure that new employees are properly onboarded and trained to complete job responsibilities. Provide oversight for the execution of the training plan and training experiences, as applicable.
Manage the quality of assigned staff's clinical work through regular review and evaluation.
Provide country-specific study start-up expertise to study start-up team leads and project teams. Review study start-up document templates, drug labels, ICF, and other applicable documents.
Helps to develop and reviews site specific recruitment materials and tools.
Perform independent quality review of submission packages, submit package to EC and HA, if required.
Collaborates with Regional Clinical Operations Manager and clinical study sites to achieve timely and complete IRB/EC submissions, ensure TMF completeness and ensure successful delivery of country site commitments, i.e. achieving site activation and enrolment goals within planned timelines, as well as maintaining inspection readiness
Contribute to feasibility, site identification, selection and evaluation.
Performs accompanied visits of CRAs to assess their performance. Review visits reports, follow-up on issue resolution and communicates with the rCSM on significant risk identified and action proposed.
Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
Anticipate and identify site issues; propose CAPAs; identify gaps and utilize opportunities, as required. Constantly strive for operating excellence, question status-quo and promote innovation.
Contributes to Clinical Operations strategy and performance against key metrics, identifying areas of improvements and propose solutions
Supervisory Responsibilities:
Mentor and manage junior staff and Clinical Research Associates
Acts as the escalation point person for CRA(s) with site related issues and concerns
Conduct mid-year and year end performance appraisals for direct reports which includes 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 required:
Minimum of 5-7 years progressive experience in clinical operations preferably including leadership activities like CRA lead or overseeing staff activities, within the biotech/ pharmaceutical sector in Italy
Prior clinical trial experience including experience in a management/leadership capacity (like CRA lead )
Experience in oncology is highly recommended
Ability to work independently and effectively handle multiple priorities in a fast-paced environment
Excellent interpersonal skills, strong organizational skills
Fluent in English and Italian (writing and speaking)
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 30-40%
Competencies:
Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.
Planning/Organizing – Able to prioritize and plan 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 - Synthesises 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 analyses 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.
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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