For one of our clients, a global leader in biotechnology based between Geneva and Lausanne, we are looking for a Clinical Affairs Specialist (M/F).
As part of a 9-month project and the launch of a product in the biotechnology market, we are looking for a candidate available immediately (within 1 month maximum). There are possibilities to continue on a permanent contract.
Your Responsibilities:
* Plan, initiate, monitor, and close out clinical trials to ensure they are conducted in accordance with protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
* Ensure compliance with FDA, EMA, and other regulatory authorities' guidelines and requirements throughout the clinical trial process.
* Prepare and maintain clinical trial documentation, including study plans, monitoring reports, regulatory submissions, and informed consent forms.
* Perform source data verification, data review, and query resolution to ensure the accuracy and integrity of clinical trial data.
* Liaise with investigators, site staff, and study sponsors to facilitate study conduct, resolve issues, and ensure timely completion of study milestones.
* Train and support clinical trial staff on protocols, procedures, and regulatory requirements.
* Participate in internal and external audits to ensure compliance with regulatory standards and company policies.
* Identify opportunities for process improvements and implement changes to enhance the efficiency and quality of clinical trials.
Your Profile:
* Bachelor's or master's degree in life sciences, or a related field.
* Prior experience as a clinical research associate (CRA) or clinical trial monitor in the biotechnology or pharmaceutical industry.
* Knowledge of clinical trial regulations, GCP guidelines, and regulatory requirements, including FDA regulations and ICH guidelines.
* Ability to manage multiple clinical trials simultaneously and meet deadlines.
* Ability to work effectively in a team-oriented environment and collaborate with cross-functional teams.
* Excellent verbal and written communication skills to convey technical information clearly.
* High level of attention to detail to ensure accuracy and compliance in all processes.
* Strong analytical and problem-solving skills to identify and address issues in clinical trials.
* Ability to adapt to changing priorities and work in a fast-paced environment.
* Available now or within 1 month.
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