Clinical Affairs Specialist

vor 4 Wochen

Geneva Lausanne, Schweiz Jobted CH C2 Vollzeit

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.

#LI-PM1

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