Referenznummer: 425648/1 Startdatum: asap Projektdauer: 6 MM++ Ort: West Switzerland
Develop and maintain core study documents (protocol, master ICF, IB, etc.)
Assist in writing annual reports, integrated medical reports, responses to regulatory authorities, and other documents requiring data summarization
Serve as primary clinical liaison with biostatistics/data management to ensure CRFs are appropriately designed
Perform data review and cleaning (incl. follow up of key findings) on an ongoing basis, including data from vendors, AE/SAE reconciliation, etc.
Develop knowledge in order to effectively understand and communicate information relating to the company’s investigational products and therapeutic areas
Contribute to pharmacovigilance data review and analysis, including participation in safety review team meetings
Develop and/or conduct training for study protocols, e.g. on disease area or therapeutic compounds and provide scientific oversight of vendors
Participate in scientific advisory boards; prepare and present clinical data at external meetings
Collaborate with Clinical Operations to identify, engage, and train potential investigators, including participation in study site visits as needed
Review/develop data review plans, statistical analysis plans, data output formats, etc. and author and/or review clinical research SOPs
Support the clinical program leaders regarding ad-hoc requests from upper management
MS degree (PhD or other advanced degree preferred) in biological sciences or similar field
Profound experience in the biopharmaceutical industry or other relevant clinical research experience, contributing to the conduct and management of multinational clinical trials
Experience in reviewing and analyzing clinical data from patients with hematologic and/or solid tumors is mandatory
Working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
Strong writing and analytic skills, ideally with experience writing/presenting clinical documents and summarizing data (e.g., patient narratives, overviews of safety, efficacy)
Experience in executing a wide range of clinical trial activities (from start-up to clinical study report)
Experience with interacting with clinical investigators and medical experts
Experience in working with Clinical Research Organizations (CROs), including vendor selection, contract negotiation, managing CRO during clinical trial setup and conduct is preferred
Demonstrated ability to work independently but also in a team and matrix environment, exercise sound judgment, and adapt to changing work environment(s)
Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is a must)
Ability to travel globally up to ~20%
The chance to help shape a fast-growing enterprise
A city with a high quality of life that perfectly embraces both modern and traditional values
A highly motivated team and an open way of communication
Attractive, performance-oriented remuneration
Dynamic and innovative market environment
Flexible working times
High degree of personal responsibility
Interesting tasks in a multinational environment
Pleasant working atmosphere
Possibilities to work in a home office
Our client is an independent and medium-sized Life Sciences company with a very agreeable company culture and is working with the latest and innovative technologies.
Über Hays: With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Einsatzort: West Switzerland
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