Role Overview - Berlin, Deutschland - Meditrial Europe Ltd.
vor 2 Wochen
Beschreibung
Company Overview:
Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe.
With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market efficiently and compliantly.
Our dedicated team of experts ensures the highest quality standards and compliance with regulatory requirements.Role Overview:
Clinical Project Manager, MD
Industry:
Lifesciences Industry:
Pharma, Medtech, Digital Health
Job Functions:
Clinical Trial Management (from study approval to study close-out)
Work Location:
Meditrial GmbH - Charlottenburg, Berlin
Requested Experience:
Minimum 5 years experience in Healthcare, Biotech, Medtech
The Project Manager is responsible for setting up, coordinating and leading clinical trials with medicines, or medical devices, leading a clinical project team consisting of Clinical Trial Assistants (CTA), Clinical Start-up specialists, Clinical Research Associates (CRA) and Data Managers.
The Project Manager is ultimately responsible for ensuring that projects are completed just in time within budget and with high level of quality and efficiency ensured by Meditrial standards.
- Over 5 + years of experience in clinical trial management medical device or drug
- Initiating and managing clinical projects in accordance with all relevant guidelines, legislation and SOPs;
- Monitoring the progress of the clinical trial in relation to the project plan and previously defined performance indicators in terms of quality and budget;
- Identify risks and develop and implement plans to mitigate risks in collaboration with team members and other stakeholders;
- Act as a daily point of contact for the sponsor and all members of the project team while conducting progress status updates;
- Reporting the progress to the internal project team, the internal and if applicable external stakeholders;
- Negotiating contracts with research centers and clinical budget;
- Master's degree in life science, healthcare management, preferred degrees include Medical Engineering, PharmD, MD, and/or PhD
- Excellent communication, negotiation and organizational skills;
- Language skills: fluent English and German are mandatory
- Previous Experience as a CRA is a plus
- Leadership skills;
- Knowledge of Good Clinical Practice (GCP)
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