Clinical Operations Manager/Senior Manager

3 weeks ago


United Kingdom Guided Solutions Full time

Our client is a clinical-stage R&D company that is developing an innovative treatment for Solid Tumour oncology.We are looking for an experienced medical device Clinical Operation Manager to join the team.
Main task of the role is to manage the clinical operational activities in Europe according to EU Medical Device Regulation (MDR), ISO 14155 (and GCPs), and national and international regulations on clinical investigations and internal procedures. Implement the Scientific and/or Clinical Feasibility Processes.
Coordinate the implementation of the Company’s clinical research program/clinical investigations, budget responsible, monitoring ISO 14155/GCP requirements.
Coordinate the implementation of the regulatory/ethical submissions for approval.
Support the finalisation of study financial agreements.
Organise and support the training of each clinical investigation dedicated team.
Coordinate the activities needed for the finalization of the operational clinical research program/CIPs, implementation and maintenance of the Company’s QMS, and Quality standards for clinical activities.
Other responsibilities relating to clinical research and data.

Relevant Medical University degree, preferred in a Pharmacy, Biology, Biochemistry, Chemistry or Biotechnology, etc.
PhD in Scientific discipline  is highly desirable.
Proven experience in the management of medical device pivotal clinical investigations for EU in private companies.
Excellent knowledge of medical device clinical investigations regulations, specifically GxP, ISO 14155, MEDDEV, MDR, and all applicable MDCGs is a must.
Excellent time and stakeholder management.
Proven project planning and implementation skills.
Excellent English language is a must.
Ability to travel regularly to sites, suppliers and management meetings.



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