Our large pharmaceutical client is looking for a candidate with strong Clinical Project Management experience within IVD and RWE projects as a Medical Alliances Operations Leader.
MAOL is the PDMA Medical Alliances Operations role responsible for providing the operational expertise and leadership to one or more cross-functional investigator initiated study (IIS) / institution sponsored research (ISR) / Real-World-Data (RWD) studies management / responsible teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP, GVP, applicable regulations and contract with Alliance Partners. The MAOL takes the initiative, launch new projects, and lead activities within PDMA Medical Alliances Operations and the IIS / ISR / RWD Community of Practices and Chapters.
The successful candidate will have between 3-5 years of hands on experience in running IVD clinical performance studies and clinical investigations of medical devices. They have a strong knowledge of regulations and standards within international clinical projects.
Tasks & Responsibilities
? 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, 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
? 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. (**)
For further information please contact Mark Cussens on firstname.lastname@example.org
- Agency: Achieva Group Limited
- Reference: BH-34049
Website: Achieva Group Limited
- Posted: 10th November 2022
- Expires: 8th December 2022