Study 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 Netherlands 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 plusSUS 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. 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.

Education Required:

BS in a relevant scientific discipline and 1-2 years of Start-up experience.

Experience in oncology global trials preferred

Computer

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 guidelines1-2 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 Dutch (writing and speaking)
Travel: up to 15%
Salary Range: 503, DKKGlobal 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.
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