Medical Alliances Operations Leader
Vor 4 Tagen
**EINFÜHRUNG**:
As a preferred supplier for Roche Basel, we are looking for an individual as
**Medical Alliances Operations Leader**:
(contract for 1 year, with possible extension). The earliest start date is as soon as possible or within 3 months. Onsite will be required, home office based on discussion.
**AUFGABENBESCHREIBUNG**:
- Provides direction and leadership to one or more study management / responsible teams or squads
- Responsible and/or contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Oversees forecasting of clinical/non-clinical supplies
- Delivers the operational elements of the study plan
- Identifies areas of best practice and process improvements
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identifies areas of best practice and process improvements
- Ensures study adherence to ICH/GCP, GVP, Roche policies and SOPs Compliance
- Will be responsible for 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.
- Will be responsible for leading and participating in cross-functional initiatives / networks in support of the continuous improvement of the global SOP for clinical investigations of medical devices.
- Will be responsible for developing process oversight mechanisms for clinical investigations of medical devices and supporting audits/inspections and CAPAs as required.
- Will be responsible for 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
**ERFORDERLICHES PROFIL**:
- Education: minimum Bachelor level ideally in Natural/Life Sciences (please note Business Administration plus relevant experience is considered)
- Has 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
- Minimum 3 to 5 years of relevant experience in international clinical project management
- Experience including the set-up of evidence generation activities for sponsored, supported or real world studies.
- Experience working with studies in all phases and experience in evidence generation
- Excellent written and verbal English skills
- Has appropriate knowledge of agile methodologies e.g. scrum, design thinking, lean etc.
***Application process**: Interested? You can find more information here:
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