Offer summary

Qualifications:

Bachelor's degree or equivalent in a relevant scientific discipline., 2-5 years of start-up experience in the pharmaceutical or CRO industry., Fluent in German and proficient in English, both written and spoken., Knowledge of clinical trial processes and regulatory guidelines such as ICH..

Key responsibilities:

Collaborate with study managers to ensure study timelines and quality standards are met.

Provide country-specific start-up expertise and support regulatory submissions.

Manage site performance and ensure inspection readiness of study documentation.

Mentor junior staff and act as escalation point for site-related issues.

Job description

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
Experience in oncology global trials preferred
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 German is a must
English (writing and speaking)
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

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 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.

Required profile