Clinical Project and Quality Manager (m/w)
To expand our current capabilities we are seeking a highly motivated
We are looking as soon as possible for a skilled individual with experience in the pharmaceutical / medical device industry. You will be responsible for the planning and execution of clinical studies in IVDs and will support the quality management department. Excellent English and German verbal and written skills are mandatory (German native speaker preferred).
- Responsible for the conduct of international clinical studies including study budget planning, CRO selection, status updates, review and control of monitoring activities;
- Responsible for the development and preparation of study related documents (protocol, IB, Patient Informed Consent, etc.);
- Submission of study documents to IRB and HA and communication to respective authorities;
- Communication with study investigators and external partners / customers;
- Development of SOPs for the department Clinical Operations;
- Support the QM department (maintenance of the quality system, release of QM documents, tracking of QM activities, participation in QM meetings);
- Reports to the Director Clinical Operations.
- Degree in pharmacy, chemistry, biology, medicine or related disciplines;
- At least two years experience as a clinical project manager in a pharmaceutical company, medical device company or CRO (experience in medical device, IVD studies preferred);
- QM expertise and hands-on laboratory experience is a plus;
- Organization and planning skills;
- Communication, negotiation and interpersonal skills;
- Ability to strategically plan, organize and manage multiple projects simultaneously;
- Sound knowledge of clinical study requirements;
- Project management skills / training.
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Über NEO New Oncology GmbH
NEO New Oncology GmbH - a third-generation diagnostics company headquartered in Cologne - is part of Siemens Healthineers. The company was founded by reputable cancer scientists Prof. Axel Ullrich and Prof. Roman Thomas. Employing best-in-class NGS based cancer diagnostics NEO New Oncology supports oncologists and pathologists in finding the best possible targeted cancer therapies for their...Mehr über die NEO New Oncology GmbH