Clinical Project Manager (all genders) Medical Devices / IVDs

Austria Job Openings

Greiner

Kremsmünster

FULL TIME

November 27, 2024

Dienstgeber: Greiner Bio-One Gmb H

Standort:Kremsmünster, AT, 4550

Frickenhausen, DE, 72636

Mosonmagyaróvár, HU, 9200

Wien, AT, 1100

Reiseausmaß: 10%

Stellentyp: unbefristet

Arbeitsform: remote

Tasks & Responsibilities

Management of complex, global multi-center IVD and medical device performance studies
Execution of clinical research projects within a defined timeline and budget
Coordination of submissions to authorities and ethics committees
Ensure compliance with high quality standards in accordance to the study protocol, standard operating procedures, ISO 14155, ISO 20916, ICH-GCP, Regulation (EU) 2017/745 (medical devices), Regulation (EU) 2017/746 (IVDs) and other local regulations
Main contact for study related questions/requirements as part of a cross-functional project team
Main contact for CROs (Clinical Research Organization), physicians and authorities
Coordination and support in contract negotiations with clinical trial sites, CROs and vendors
Creation of study concepts, plans and reports as well as project-related plans such as monitoring plan, project management plan
Creation of SOPs, forms and other relevant study or process documents

Required Capabilities / Competences

Degree in life sciences or equivalent combination of education, training and work experience in clinical trials
At least 3 years of experience as a Clinical Project Manager (CPM) or 5-6 years as Clinical Research Associate (CRA) at a CRO/medical device or pharmaceutical company
Good knowledge of current industry practices related to the conduct of clinical studies (ICH-GCP, ISO 14155, ISO 20916)
Good knowledge of MDR and IVDR is a must
Knowledge of FDA requirements related to IVDs and MDs, ISO regulations and CLSI guidelines are beneficial
Good understanding of the GDPR
Ability to work independently and reliably in managing multiple projects (international) and in a fast-paced and changing environment
Excellent spoken and written English
Excellent presentation, communication and diplomacy skills, with the ability to negotiate and resolve conflicts

Our Offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. Due to legal requirements in Austria, we are obligated to disclose the minimum gross salary for the position as defined by the collective agreement which amounts to EUR 63.596,32 (collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

Wir stehen als Arbeitgeber für Chancengleichheit und berücksichtigen alle qualifizierten Bewerber:innen unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Wir haben uns das Ziel gesetzt, den Frauenanteil in Führungs- und Expertenfunktionen zu erhöhen und ermutigen daher qualifizierte Frauen sich zu bewerben.

Job ID: 2295

We regret to inform you that this job opportunity is no longer available as it has expired

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