For our client, a global pharmaceutical company based in the Basel area we are accepting applications from highly qualified individuals for the position of
Clinical Trial Leader (m/f, 100%)
The successful candidate will be responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). They will function as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP).
Function as Clinical Trial Leader for assigned phase I/II studies (scientific and/or operational complexity) including multi-country / multi-center trials.
Author of the clinical study protocol, amendments and related documents. Informed Consent Form, monitoring plan and other study essential documents.
In collaboration with the Medical Expert and CTT, coordinate the ongoing medical / scientific review of the clinical trial data (as needed) coordinate the data analysis and interpretation including the development of first interpretable results.
Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. Communicate study progress to CTT, CS&I Management, TA Heads and project team members.
Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure report is completed according to current requirement. Responsible for report publication.
Requirements
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
At least 5 years relevant experience in clinical trials / drug development (e.g. study management in a multinational environment using different models for trial execution).
Track record of successfully managing multiple, concurrent phase I and IIa complex clinical trials.
Fluent written and oral English.
Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
Your Horizons
Attractive compensation package
Modern work location with excellent access to public transport
