BeOne 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
- Responsible for start-up activities in Spain 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
SSUS Activities
Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiationsRetrieves 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 milestonesEnsure inspection readiness of start-up study and site documentationCollaborates with Regional Clinical Operations Manager / Start-up Lead and clinical study sites to ensure timely delivery of start-up milestonesEvaluates 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.Sr. SSUS Responsibilities
Mentor and manage junior SSU staffActs as the escalation point person for SSUS(s) with site related issues and concernsMay serve as subject matter expert for clinical operations, country regulations and SSU-related activities.Education Required
BS in a relevant scientific discipline and 2 years of Start-up experience.Experience in oncology global trials preferredComputer Skills
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines2-5 years of Start-up experience in the pharmaceutical or CRO industryExcellent communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskFluent in English and Spanish (writing and speaking)Travel : up to 15%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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. BeOne 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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