Senior Study Start-Up Specialist

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company 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 Belgium 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 reputed company 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

• Retrieves essential documents from study site and performs essential document site file reconciliation. reputed company independent quality review of submission packages, submit package to EC (and HA), if required.

• Review and translate drug labels, reputed company, 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 reputed company and clinical study sites to ensure timely delivery of start-up milestones

• Evaluates the quality and reputed company 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-reputed company and promote innovation.

Sr. SSUS responsibilities

• Mentor and manage junior SSU staff

• Acts as the escalation reputed company person for SSUS(s) with site reputed company issues and concerns

• May serve as subject matter expert for clinical operations, country regulations and SSU-reputed company activities.

Education Required:

• BS in a relevant scientific discipline and 2 - 5 years of Start-up experience.

• Experience in oncology global trials preferred

Computer Skills:   Efficient in reputed company Word, reputed company, MS Project, MS PowerPoint and Outlook

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• 2-5 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.

Travel:  up to 15%

Salary Range UK: 52,000.00 GBP - 65,000.00 GBP

Global Competencies

reputed company we exhibit our values of Patients First, Driving Excellence, reputed company 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 reputed company
• reputed company 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, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need.