Medical Alliances Operations Leader

vor 1 Woche

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**The Life Science Career Network**

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of both in vitro diagnostics and manufacturing and selling of several innovative drugs. We are currently looking for an enthusiastic job title, offering an initial **contract **of 12 months with high chances of extension to an open ended / unlimited contract to be based in **Basel **for a:
**Clinical Project Manager, IVD studies**

**Main Responsibilities**:

- Developing and maintaining processes, guidance, training materials and tools for IVD clinical performance studies and clinical investigations of medical devices in line with the above regulations and standards - to enable compliant implementation of the global SOP for clinical investigations of medical devices;
- Leading and participating in cross-functional initiatives / networks in support of the continuous improvement of the global SOP for clinical investigations of medical devices;
- Developing process oversight mechanisms for clinical investigations of medical devices and supporting audits/inspections and CAPAs as required;
- Providing expertise to study teams as required regarding the scope of IVD clinical performance studies and clinical investigations of medical device per IVDR EU 2017/746 and MDR EU 2017/745 regulations and ISO 201916 and ISO 14155 standards
- Overseeing forecasting of clinical/non-clinical supplies;
- Providing the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work.

**Qualifications and Experience**:

- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Minimum Bachelor level ideally in Natural/Life Sciences (please note Business Administration plus relevant experience is considered);
- Minimum 3 to 5 years of relevant experience in international clinical project management for medical devices;
- Hands-on experience in running IVD clinical performance studies and clinical investigations of medical devices;
- Strong knowledge of IVDR EU 2017/746 and MDR EU 2017/745 regulations and ISO 201916 and ISO 14155 standards;
- Experience including the set-up of evidence generation activities for sponsored, supported or real world studies;

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