Ort: Switzerland - Meyrin/Geneva
Firma: OM Pharma
OM Pharma, Geneva, are searching for a Clinical Trial Supplies Coordinator, responsible to provide oversight of all activities in the clinical supply chain including manufacturing, ordering of bulk supplies, packaging, labelling, distribution, blinding, randomisation, import and export licensing, management of tracking systems, drug release documentation, quality control and quality assurance activities and returns. You will work in a cross-functional environment and report to the Clinical Operations Lead. Your tasks and responsibilities will include, but not be limited to, the following:
- Conduct and oversee all supply chain activities and document design (labelling) for company-sponsored and investigator-initiated studies according to OM Pharma SOPs, cGCP, cGMP, and all applicable regulations
- Liaise with and oversee Clinical vendors for management of clinical supplies in compliance with appropriate regulations
- Work with Clinical Trial Managers to formulate and prioritise short- and long-term objectives with respect to clinical supplies and implement strategies to meet these objectives
- Work with Clinical Operations team in planning timelines and budget for clinical trial supply chain activities, including the related risk management plan
- Contribute to the definition of outsourcing and insourcing strategy for the assigned clinical trial supplies blinding, packaging & labelling and distribution activities and define the related budget
- Ensure clinical trial supplies are ordered, managed, and delivered within agreed budget and timelines
- Prepare batch record documentation or review the providers’ batches record documentation (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, providing a source of process improvement targets and ideas
- Maintain relationships with pharmaceutical partners and their Clinical Trial Supply (CTS) groups
- Work with Logistics team in developing and implementing process improvement plans and structure in relation to clinical trial supply management
- Ensure appropriate, comprehensive and professional communications both internally and externally
- Participate in Clinical Study Team meetings to provide CTS status updates and advice
- Perform additional clinical operations or administrative tasks and support Clinical Operations team as needed
- Write and revise departmental SOPs in support of clinical supply activities
The ideal candidate has a University degree in a relevant scientific field in addition to the following skills and experience:
- Minimum of 3 years’ experience in the pharmaceutical industry in clinical operations
- Good knowledge of GMP, GMP related documentation and GCP
- Management experience in clinical trial supplies and associated regulatory requirements
- Project coordination and budget experience
- Experience in coordinating clinical trial materials, labelling, packaging and distribution to trial centres
- Knowledge of the drug development process and clinical development planning
- Successful experience in coordinating internal and external resources and in working with pharmaceutical partners
- Fluent in English and French
You have excellent verbal and written communication skills and are able to interact professionally and productively in a cross-functional environment. You have excellent attention to detail and work to high ethical standards and integrity. You bring broad clinical and operational knowledge, demonstrating continuous expanding and learning ability. You act as a role model for the OM Pharma values.
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.