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Clinical Affairs Specialist (M/F), Lausanne
Client:
LHH
Location:
Lausanne
Job Category:
Other
Job Reference:
6797af25f498
Job Views:
3
Posted:
17.02.2025
Expiry Date:
03.04.2025
Job Description:
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:
1. 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.
2. Ensure compliance with FDA, EMA, and other regulatory authorities' guidelines and requirements throughout the clinical trial process.
3. Prepare and maintain clinical trial documentation, including study plans, monitoring reports, regulatory submissions, and informed consent forms.
4. Perform source data verification, data review, and query resolution to ensure the accuracy and integrity of clinical trial data.
5. Liaise with investigators, site staff, and study sponsors to facilitate study conduct, resolve issues, and ensure timely completion of study milestones.
6. Train and support clinical trial staff on protocols, procedures, and regulatory requirements.
7. Participate in internal and external audits to ensure compliance with regulatory standards and company policies.
8. Identify opportunities for process improvements and implement changes to enhance the efficiency and quality of clinical trials.
Your Profile:
1. Bachelor’s or master’s degree in life sciences, or a related field.
2. Prior experience as a clinical research associate (CRA) or clinical trial monitor in the biotechnology or pharmaceutical industry.
3. Knowledge of clinical trial regulations, GCP guidelines, and regulatory requirements, including FDA regulations and ICH guidelines.
4. Ability to manage multiple clinical trials simultaneously and meet deadlines.
5. Ability to work effectively in a team-oriented environment and collaborate with cross-functional teams.
6. Excellent verbal and written communication skills to convey technical information clearly.
7. High level of attention to detail to ensure accuracy and compliance in all processes.
8. Strong analytical and problem-solving skills to identify and address issues in clinical trials.
9. Ability to adapt to changing priorities and work in a fast-paced environment.
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