Aktuelle Jobs im Zusammenhang mit Clinical Supply Coordinator - Freiburg, Freiburg - OM Pharma Ltd.

Location:

Meyrin, Geneva, CH- Division:

• Division: Clinical Development
• Job Type: Limited-contractTo strengthen our Clinical Operations team, we are recruiting a
  Clinical Supply Coordinator based at our headquarters and biotech production site in Geneva, for a 1-year fixed-term contract. Reporting to the Clinical Supply Manager, your mission is to support with the oversight of all activities in the clinical supply chain, for Clinical programs and Investigator Initiated Studies (IIS).

Your main responsibilities are as follows:

• Conduct and support oversight of all supply chain activities (manufacturing / ordering of bulk supplies, packaging, labelling, distribution, blinding, randomization, import/export licensing, tracking systems, drug release documents, quality control/assurance, returns, etc.)
• Liaise with and support oversight of Clinical vendors for management of clinical supplies in compliance with appropriate regulations
• Support the Clinical Supply Manager in planning timelines and budget for clinical trial supply chain activities, including the related risk management plan
• Ensure clinical trial supplies are ordered, managed, and delivered within agreed budget and timelines
• Prepare batch record documentation and coordinate Product Summary File (PSF) completion or review the providers' batches record documentation / PSF (in case of outsourced activities) for the blinding, shipment, packaging and labelling of clinical trial supplies and file in eTMF
• Maintain active inventory tracking for clinical investigational products and supplies
• Support the development and implementation of processes and standards and provide a source of process improvement targets and ideas

To carry out this mission, we are looking for a person with the following profile:

• Scientific educational background (Bachelor's or Master's degree)
• About 2 years of pharmaceutical industry experience in clinical trial supply activities
• Good understanding of the drug development process and clinical trial planning and execution, familiar with clinical trial documentation and regulatory requirements
• Good knowledge of ICH GCP and GMP Annex 13 and managing related documentation
• Fluent in French and English

You describe yourself as an organized, pragmatic and solution-oriented person.

Thanks to your communication skills and your team spirit, you integrate quickly into a new environment and easily establish collaborative links with different stakeholders.

Finally, you feel comfortable in a fast-paced environment and like to take initiatives to move things forward.

Do you want to develop your skills in clinical operations within a vibrant and innovative company? Seize this opportunity to join OM Pharma and take part of our journey to help patients around the world to live better lives

About Us:

OM Pharma is a global Geneva-based biopharmaceutical company.

It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.

It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.

The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

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