Clinical Operations Manager
3 weeks ago
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.
The position has a key role for ongoing clinical activities at all EU trial sites including any safety-related investigational product-related issues.
The role reports to Head of Clinical Operations.
Responsibilities:
- Managing all clinical operations, coordination with clinical sites, vendors.
- Ensuring successful communication of ongoing clinical activities at all EU trial sites including any safety-related investigational product-related issues.
- Support the qualification process of clinical Vendors (CROs, laboratories, providers of specialised services, etc.).
- 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 preparation of the study CORE documentation.
- 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.
Key Requirements:
- 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.
- Hands-on attitude, problem-solving capability and excellent organisational skills.
- Great communication and presentation skills.
- Ability to work is small and cross-functional teams.
- Excellent English language is a must.
- Ability to travel regularly to sites, suppliers and management meetings.
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