Study Start-up Specialist/Senior 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, reputed company 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 reputed company to ensure study timelines are adhered to and required quality standards are maintained.
• CRA experience is considered a plus

SSUS activities

• reputed company country-specific study start-up expertise, assist on start-up activities, reputed company 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. reputed company independent quality review of submission packages, submit package to EC (and HA) or support CTIS Submission
• 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 Study 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 reputed company, question status-reputed company and promote innovation.
• Initiate, support or reputed company process improvement initiatives

Senior 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.

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,reputed company,MSProject,MSPowerPointand Outlook

Travel:upto 15%

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, 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 reputed company and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, merit, and business need.

Originally posted on Himalayas