Clinical Trial Leader

An experienced Clinical Trial Leader is required to join a global pharmaceutical company onsite in Basel.

Working on Phase I/II multi-country/multi-centre trials, the successful candidate will be responsible for the management and clinical execution of assigned clinical trials within the Translational Medicine group. The CTL will be responsible for the planning and implementation of all operational aspects of assigned clinical trials from study concept to reporting according to timelines, budget, operational and quality standards.

What you will be doing:

• Responsible for leading and matrix managing the multidisciplinary team and support functions as assigned
• Author of the clinical study protocol and other study essential documents. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
• In collaboration with outsourcing/planning/feasibility personnel, clinical trial team, Local CO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).
• Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
• Oversee Trial Master File for assigned studies
• Chair meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.
• Regularly update all trial information databases in order to manage accuracy of information.
• Review and approve all study payments as per financial agreements.
• Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
• Assist in data review and interactions with the Data Manager, Statistician, and third parties
• Assist in the co-ordination of medical / scientific review of the clinical trial data, and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations.

• Responsible for the coordination of pre-audit activities for nominated projects

What you can bring to the role:

• Fluent spoken and written English
• Comprehensive experience in clinical trial management
• Demonstrated leadership and problem-solving skills.
• Track record of managing multiple, complex clinical trials.
• Ability to interact with a wide range of people and build strong positive relationships. Potential for customer orientation awareness and focus.

What you get in return:

• A competitive hourly rate
• A 12 month contract with a global pharmaceutical giant
• The opportunity to work within a global team on early phase studies across a variety of therapeutic areas

What to do next:

• Please apply now with an updated CV in order to arrange a confidential discussion