Senior Clinical Research Manager - Geneva

☞ OM Pharma

View: 149

Update day: 21-03-2024

Location: Meyrin Genève GE

Category: R & D IT - Software

Industry: Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

In view of our continued global growth, we are looking for further support and recruiting a Senior 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
  • Develop Clinical Development Plans of projects within the OM Pharma project portfolio
  • In collaboration with a cross-functional team, develop effective and innovative clinical trial designs, and support execution of clinical trials by supporting the clinical operation team
  • 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
  • Serve as a deputy of the Head of Clinical Development as needed
  • 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 10 years of pharmaceutical industry experience
  • Solid experience clinical trial design and protocol development, data analysis, statistics and research methods
  • Excellent 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
  • Knowledge and experience in immunology, infectious disease, or respiratory clinical trials desired

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!

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 .
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Deadline: 05-05-2024

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