OM Pharma is a global Geneva-based Biotech 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 continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.
In view of our continued global growth, we are looking for further support and recruiting a Clinical Research Manager at our biotech production site in Geneva. Reporting to the Head of Clinical Development, your mission is to provide medical and scientific support to ensure the development, execution and monitoring of clinical trials. Your main responsibilities are as follows:
- In collaboration with a cross-functional team, contribute to the development of effective and innovative clinical trial designs, and facilitate execution of clinical trials by supporting site and CRO personnel, safety monitoring activities, data clean-up activities, data analyses, and clinical study report development and finalisation
- Author protocols and provide scientific input into manuscripts, publications, IBs, regulatory and clinical study reports
- Research and analyze scientific/medical information and data with respect to clinical trials, safety databases, and other elements necessary for decision-making and regulatory submissions
- Assess safety data for ongoing clinical trials and manage DSMB processes
- Represent the company as the scientific subject matter expert at external meetings
- Provide Medical Oversight and Medical Monitoring to interventional clinical trials
- Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed
- Evaluate investigator-initiated study protocols and make recommendations
- Provide trainings for internal staff, service providers or investigators
For this position, business travels are required, around 5-10% of working time.
To carry out this mission, we are looking for a person with the following profile:
- Degree in the fields of Life Sciences / Health (Master, PhD, PharmD)
- At least 5 years of pharmaceutical industry experience
- Knowledge and experience of clinical trial design, data analysis, statistics and research methods
- Knowledge of the drug development process and clinical research methodologies
- Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development
- Business fluent in English and French
You like to work independently and in a fast paced, hands-on, flexible and dynamically changing environment. Thanks to your communication and interpersonal skills, you easily establish collaborative links with others. Endowed with an entrepreneurial spirit, you feel comfortable in a position where you make recommendations and take initiatives to move things forward. Finally, you define yourself as a solution-oriented and methodical person who drives novelty.
Are you interested in this position? Then apply now and join OM Pharma!