Clinical Trial Associate

vor 2 Wochen

Genf, Genf, Schweiz OM Pharma Ltd. Vollzeit

Location:

Meyrin, Geneva, CH- Division:

  • Division: Clinical Development
  • Job Type: Limited-contractTo cover a temporary internal transfer and complete the Clinical Operations team based at our Geneva headquarters, we are looking for a
    Clinical Trial Associate available as soon as possible and until mid-July 2024. Reporting to the Clinical Trial Associate Lead, your mission is to ensure ICH-GCP compliant performance of clinical trials and support the Clinical Operations team.

Your main responsibilities are as follows:

  • Support operational execution of global clinical trials, from start-up activities until study close-out
  • Ensure operational support of clinical study teams including taking and distributing meeting minutes and follow up action items
  • Interact with project team and external service providers including CRO(s), subcontractors, to assist with timely and efficient study start up activities including site feasibility management and site set up including management and tracking of site contracts, study insurances, EC or regulatory approvals and other trial related documentation
  • Setup, manage and maintain ICH GCP compliant Trial Master File and assist in review and audit of vendor Trial Master File to ensure compliance
  • Develop and maintain appropriate tracking tools for trial related metrics
  • Draft and/or provide input into department SOPs and procedures
  • Support CST members in the coordination of contracts with sites/vendors/KOL
  • Assist in organization of Investigator's meetings
  • Ensure that trial invoices are processed in a timely manner, maintain financial records for each study and invoice tracking list
To carry out this mission, we are looking for a person with the following profile:

  • Scientific educational background (Bachelor's degree or equivalent degree)
  • At least 3 years of experience in clinical trial support in the Pharmaceutical Industry or CRO
  • Good understanding of the drug development process, familiar with clinical trial documentation and regulatory needs and ICH GCP requirements
  • Fluency in English with good oral skills in French
  • Excellent user of Office Programs (Word, Excel, PowerPoint)
  • Ability to travel, as required
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 other departments or 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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