Study Start-up Specialist page is loaded Study Start-up Specialist Apply locations Italy Remote Milan time type Full time posted on Posted 7 Days Ago job requisition id R23608 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. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION General Description: Responsible for start-up activities in Italy and provides local expertise. Identify gaps and areas for improvement and propose CAPA. The Start-up specialist is responsible for collaborating closely with the Regional Clinical Operations Manager/Start-up Lead to ensure study timelines are adhered to and required quality standards are maintained. CRA experience is considered a plus Essential Functions: Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiations Retrieves essential documents from study site and performs essential document site file reconciliation. Perform independent quality review of submission packages, submit package to EC (and HA), if required. Review and translate drug labels, ICF, site specific recruitment materials and other applicable documents. Manages sites and site performance by tracking regulatory submissions and relevant milestones Ensure inspection readiness of start-up study and site documentation Collaborates with Regional Clinical Operations Manager/ Start-up Lead and clinical study sites to ensure timely delivery of start-up milestones Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation. Minimum Requirements – Education and Experience: BS in a relevant scientific discipline and 2years of Start-up experience. Experience in oncology global trials preferred Other Qualifications: Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines 2 years of Start-up experience in the pharmaceutical or CRO industry Excellent communication and interpersonal skills Excellent organizational skills and ability to prioritize and multi-task Fluent in English and Italian (writing and speaking) Travel: up to 15% Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook 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. About Us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter). To Mainland China Candidates For more information, please visit the link to explore job opportunities in China Mainland. At BeiGene, how we work is just as important as the work we do . Below are our Values that determine the decisions we make and how we do things. #J-18808-Ljbffr
