Clinical Study Manager, International Trials
Clinical Project Manager, International Trials, Growing Team for Clinical Development and Operations
We are currently mandated to hire two new clinical study managers for an ambitious and growing pharmaceutical company in the Zug/Zurich area. The company have had a big injection of cash, they already have established products and have a number of interesting RX products entering phase II-III. What I like about this company and the team is that the clinical department have been together for a long time and have a huge amount of experience dealing with complex trials and protocols. With this in mind it is a great place to learn and to further develop in your career.
- One day homebased is an option
- Growing team with solid future career steps
- Small molecule pharmaceuticals within immunology
- Modern offices with phenomenal transport links
- Manage all operational aspects of global clinical studies from initial study concept to final report within the scope of the company's development plan
- Coordinate and oversee the development of study protocols, and cooperate in the development of other essential documents for clinical studies, providing expert scientific input throughout.
- Manage all required protocol amendments/deviations.
- Support evaluation, selection and management of Clinical Research Organizations.
- Obtain expert scientific/medical/regulatory input from external consultants at appropriate stages of development
- Give input at meetings and interactions with health authorities and in response to questions posed by health authorities and ethics committees/IRB's worldwide, where appropriate.
- Provide scientific input in the design and implementation of clinical development strategies and global clinical development plans
- Stay abreast of regulatory requirements and guidelines and current trends in the fields of products in development.
- Survey clinical program time lines, budgets, and strategies.
- Report issues, shortcomings, bottle necks where necessary to superiors and propose risk mitigation actions.
- Support cross-functional scientific team of internal and, if required, external stakeholders involved in the different phases of drug development
- Through the clinical development team, assure timely initiation and completion of studies ensuring high quality and credible data.
- Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs and NDA, and other clinical trial and regulatory submissions.
Experience and skills ideally required for the position:
- Over 5 years experience in the Pharmaceutical sector
- Experience as a clinical project manager for Pharma
- Experience in writing clinical protocol and managing clinical budgets
- Life science degree
- Fluency in English
For a confidential discussion about regulatory affairs, or to apply, then send your CV to firstname.lastname@example.org or call me, Matt Beedle, Consultant for Switzerland on +41435 080817 .
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