Study Start-Up Specialist Venezia

Study Start-Up Specialist
Venezia
Veneto, Venezia

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 CONSIDERATIONMANDATORY EXPERIENCE: PHARMACEUTICAL/BIOTECH INDUSTRY, HEMATOLOGY, ONCOLOGYGeneral DescriptionResponsible 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 FunctionsProvide 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 ExperienceBS in a relevant scientific discipline and 2 years of Start-up experience. Experience in oncology global trials preferred. Other QualificationsUnderstands 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). Travelup to 15%Computer SkillsEfficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook. CompetenciesEthics - 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. 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 analyses information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. BeiGene Global CompetenciesWhen 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe 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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