Senior Clinical Trial Manager

Hobson Prior are seeking a Senior Clinical Trial Manager to join our client on a permanent basis in Basel. Our client is focused on pioneering medical research by developing innovative therapeutics.

Please note that to be considered for this role you must have the right to work in this location.

Key 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.
• 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.
• Ensure all documents are delivered on time to meet submission targets to Health Authorities and Ethics.
• 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.
• Provide regular updates on operational clinical trial level activities for internal reporting.
• Responsible for the development and management of study timelines, risk and quality plans.
• Responsible for the Trial Master File completeness for audit/inspection readiness and investigator site files.

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).
• Fluent in both written and spoken English. Any additional language is an asset.
• Relevant working/residency permit or Swiss/EU-Citizenship is preferred.
• Experience in managing all operational aspects of clinical trials from initiation to closure and in leading the development of study-related documents.
• Previous exposure to working Phase I and II trials with experience across the whole Clinical Operations & Development process.
• Experience in oncology / hematology is an asset.
• Solid track record on the management of ESPs and Third-Party Vendors.
• Very good knowledge of ICH-GCP and clinical trial process.
• Experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.