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Associate Director, Global Feasibility
vor 3 Wochen
- Accountable for the development of the feasibility strategy across clinical programs and delivering its end to end process.
- Lead and manage the global feasibility and collaborate with internal functional area leads (e.g. Regulatory Affairs, Clinical Vaccine Group) to build knowledge on study and country interest and feasibility and help to respond to the external environment.
- Pro-actively improve cross-business collaboration and leverage site relationships, data analytics and internal cross-functional knowledge / expertise to build intelligence.
- Leverage historical, scientific, epidemiologic and competitive data to identify and evaluate new regions / countries in line with the company strategy and in collaboration with Global Medical Affairs and Commercial group.
- Collaborate with the Program Director / Clinical Science & Strategy and Global Clinical Program Manager to provide analyses and data for scenario planning and country strategy, including region / country identification and evaluation.
- Ensure effective collaboration with external service providers to further build feasibility and country strategy for a given study including mitigations for enrolment.
- Ensure oversight of the enrolment strategy and mitigations until the study has completed enrolment
- Ownership of the Feasibility Mobilization process. Establish, implement and manage standards and processes for initiating study planning and feasibility activities, including build of data driven study assumptions from protocol go through feasibility completion.
- Full support of the feasibility process. Maintain continuity across studies by documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning.
- Partner with Clinical Operations management to implement processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility at both the country and site level, as well as the timing of key recruitment milestones.
- Upholds and promotes the Company’s reputation externally by demonstrating high professional standards and integrity in all external contacts.
- Maintains up to date knowledge of the Study Operations landscape, industry best practices and regulatory considerations.
- BS / BA degree required - Graduate degree desirable in a relevant field such as Operations, analysis, healthcare, MBA
- 10+ years of Clinical Operations experience , including detailed assessment / analysis and reporting of program operational plans and options
- Experience in overseeing complex and multi regional Global Clinical Trials
- Track records of strategically advising leaders on operational environment and best ways to succeed in plan execution.
- Track record of using diverse datasets for purposes of analysis and intelligence
- Demonstrated proficiency in advanced MS Project, Microsoft Word, PowerBI
- Experience in overseeing complex and multi-regional Global Clinical Trials
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Associate Scientist QC Raw Materials
vor 3 Wochen
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Associate Scientist QC Raw Materials
vor 3 Wochen
Berne, Schweiz Randstad (Schweiz) AG, co Johnson & Johnson Vollzeit#slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...