Clinical Research Manager 80-100% - Limited Contract (6 months) - Geneva

To cover a maternity leave, we are recruiting a Clinical Research Manager 80-100% based at our headquarters in Geneva, for a 6-months limited contract. Reporting to the Clinical Research Head, your mission is to provide clinical research expertise emphasizing the generation of new clinical evidence in the field of bacterial lysates for immune health. Focusing on one Real-World Evidence Study, you act as subject-matter expert in all clinical science activities on the study, in particular for data analysis and interpretation, Clinical Study Report (CSR) writing and data dissemination. In addition, you provide support for a Phase 2b Study, in particular for Medical Monitoring and the organization of Data Monitoring Committee (DMC) processes. You also closely collaborate with cross-functional teams (such as Clinical Operations, Regulatory, Biostatistics and Safety teams) and external stakeholders to support clinical study execution in compliance with GCP.

Your main responsibilities are as follows:

• Collaborate closely with the internal Clinical Research Team, Biostatisticians, and CRO to ensure proper analysis and accurate data interpretation, aligned with literature reviews and field standards.
• Work closely with clinical, regulatory, and statistical teams to ensure smooth execution of data-related deliverables; support team discussions by providing medical/scientific input into results interpretation.
• Author, review, and finalize Clinical Study Reports (CSRs), ensuring alignment with regulatory standards and clinical trial outcomes. Collaborate with cross-functional teams to ensure the integration of statistical and clinical findings into comprehensive CSRs. 
• Work closely with Clinical Research Head to integrate results findings into Clinical Data Dissemination Plan.
• Provide medical and scientific insights to ongoing clinical trials, including the evaluation of blinded interim data; identify and review protocol deviations, ensuring proper documentation and action according to regulatory standards.
• Provide access to accurate and up-to-date trial data to Data Monitoring Committee members for decision-making.
• Actively participate in the Clinical Study Team, collaborating with cross-functional teams to ensure seamless study execution.  
• Author and review key scientific and regulatory documents, including Investigator Brochures (IBs), study protocols, and committee charters, regulatory briefing books ensuring accuracy and scientific rigor. 
• Provide scientific input into regulatory submissions, addressing authorities' questions effectively by presenting clinical trial findings with clarity and precision.

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

• Master’s, PharmD or PhD in Life Sciences or a related field
• At least 3 years of experience in clinical research and medical writing
• Experience in clinical research methodologies, publications writing and data dissemination 
• Experience in the fields of data analysis, statistics and interpretation
• Experience in real-world evidence studies methodologies is a plus
• Knowledge of GCP regulations, ICH and FDA guidelines relevant to Clinical Development
• Business fluent in English, with, ideally good oral skills in French 
• Proficiency in Ms-Office tools

You enjoy working in a fast-paced, agile and flexible environment. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with cross-functional and multi-cultural teams. Finally, you describe yourself as solution oriented and you like to take initiative to move things forward.

Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!

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.

For more information, visit the website: ompharma.com.