Study Start-up Specialist/Senior Start-up Specialist

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 Germany and Austria 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 Study 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 negotiations
• Follow and/or support (if needed) AMG or GCP-V requirements as requested by German/Austrian laws
• 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) or support CTIS Submission
• 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 Study 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.
• Initiate, support or lead process improvement initiatives

Senior SSUS responsibilities

• Mentor and manage junior SSU staff
• Acts as the escalation point person for SSUS(s) with site related issues and concerns
• May serve as subject matter expert for clinical operations, country regulations and SSU-related activities.

Qualifications:

• BS or equivalent in a relevant scientific discipline
• Experienceinoncologyglobaltrials preferred
• UnderstandsclinicaltrialprocesseswithathoroughknowledgeofICHandassociatedregulatory guidelines
• 2-5yearsofStart-upexperienceinthepharmaceuticalorCRO industry
• Excellentcommunicationandinterpersonalskills
• Excellentorganizationalskillsandabilitytoprioritizeandmulti-task
• FluentinGerman is a must
• English (writingandspeaking)
• EfficientinMicrosoftWord,Excel,MSProject,MSPowerPointand Outlook

Travel:upto 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 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. 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.

Originally posted on Himalayas