📍 Location: Allschwil, Switzerland🇨🇭
📅 Schedule: Full-time (100%)
⏳ Duration: 12 months
🚀 Start Date: ASAP
Are you a medical professional with a passion for clinical research and drug development? We are looking for a Clinical Operations Manager to join a team in Basel, Switzerland!
This role offers the opportunity to contribute to cutting-edge clinical trials while ensuring compliance with Good Clinical Practices (GCP) and regulatory standards.
Key Responsibilities:
– Managing the operational trial related activities in close collaboration with other functions
– Leading the development of External Service Providers (ESP), specifications, testing and implementation in collaboration with other functions, and ensuring appropriate quality control of deliverables
– Supervising the deliverables towards the CRO and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Clinical Trial team (CTT)
Additional responsibilities include:
– Leading the development of trial-related operational documents
– Acting as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions
– Actively participating in Investigator meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits.
What We’re Looking For:
– Bachelor of Science degree or equivalent University degree in life sciences or healthcare
– 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
– Experience in working in global cross-functional (matrix) and multicultural teams
– Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management
– Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
– Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
– Position may require international travel.
Language skills
– Excellent verbal and written communication skills in English;
Apply:
For more information or to apply please contact Hendre Moolman on hmoolman@ckqls.ch
Please quote job reference 128999 in all correspondence.
