Clinical Trial Manager

Proclinical has partnered with an innovative biotech company in search for a talented Clinical Trial Manager in Basel. You will have the opportunity to work in a dynamic environment with possibilities to elevate the company's growth.

Job Responsibilities

• Responsible for the operational conduct and management of assigned clinical trial(s) in close collaboration with other functions, including the development of the clinical study protocols and related documents
• Contribute to the development of regulatory documents (e.g. IB / IMPD / DSUR) and responses to Health Authorities/Ethics
• Ensure all documents are delivered on time to meet submission targets to Health Authorities and Ethics
• Responsible for delivering clinical activities on the assigned trials towards the CROs and other External Service Providers (ESPs) selected for the trial, to ensure compliance with study protocol and in accordance with scope of work/budget
• Selection and training of ESPs
• Responsible for the development, management and tracking of the clinical trial budget, including timely and accurate communication for internal reporting
• Prepare and formulate critical decisions, mapping out options and obtain internal approval
• Proactively identify deficiencies and new risks in trial conduct, suggest corrective actions in timely fashion and escalate internally, as required
• Responsible for the Trial Master File completeness for audit/inspection readiness and investigator site files
• Contribute in forecasting drug supply needs
• Ensure and support feasibility activities as needed
• Responsible for all study-related meetings and training sessions
• Supporting the development of internal SOPs and the conduct of audits, as needed
• Assume responsibility for other projects or trial-related duties as assigned

Skills and Requirements

• MSc or PhD (preferred) in Life Sciences / Healthcare or equivalent
• 8-10+ years of experience in the field of Clinical Trials (either CRO or industry/biotech experience)
• Experience in managing all operational aspects of clinical trials
• initiation to closure and in leading the development of study-related documents
• Previous exposure to working on oncology Phase I and II trials, is a major asset
• Fluent in both written and spoken English. Any additional language is an asset

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

#LI-FL1