Clnical Trial Manager - Late Phase - Fixed term contract

Sto attualmente collaborando con una societa' farmaceutica di livello mondiale, con una pipeline di prodotti assolutamente innovativa e di grandissimo interesse per tutta la comunita' scientifica. La posizione e' di Clinical Trial Manager, ossia il punto di riferimento per tutto cio' che riguara le gestione e coordinamento di Clinical Trials, esclusivamente nella Late Phase della clinical research.

Job description:

• Contributes to Clinical Operations International team activities
• Under supervision, participate in or lead departmental strategic initiatives
• Evaluates scientific proposals or protocols to identify logistical, regulatory or contractual implications
• Being operational contact with external investigators and internal stakeholders
• Manages assigned studies by establishing strong partnerships with external investigators and internal collaborators
• Manages study drug planning and shipping activities
• Provides regular local and global study updates to the appropriate internal stakeholders
• Maintains internal Clinical Operations databases and clinical study data and document repositories
• Maintains current knowledge of local legislation regarding execution of post-authorisation studies
• Ensures local consistency & alignment with global process & procedures
• Works with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
• Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines
• Contributes to development and maintenance of post-authorisation study budgets
• Manages CROs/vendors for assigned post-authorisation studies
• Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and study reports

Requirements:

• 4+years relevant as Trial/Study Manager in Phase IV and Non-Interventional studies
• Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Fluent english
• Availability of working with 1 year fixed term contract

Se interessati ad approfondire, inviate gentilmente il cv a g.ballabio@nonstop-recruitment.com

If you are interested, then get in touch with Giona Ballabio by applying below, or by sending an email on: g.ballabio@nonstop-recruitment.com.

You can also connect with me on LinkedIn and send your Cv to me in a word format on the email found on my profile or find more opportunities that we have available on Nonstop's website. I am a specialised recruiter within Clinical Research in the Pharma industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat. If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic, and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.