Clinical Project Manager - Medical Device job in Berlin, Germany

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: Germany

This vacancy has now expired. Please see similar roles below...

An opportunity has opened for an experienced Clinical Project Management professional to join a young & growing Medical Devices company based in Berlin. This is a newly created role within the company and you'll be the first person in the Clinical team, so you'll need to be a well experienced and capable individual to succeed in this position.

You'll be taking the lead in developing, conducting, evaluating/ documenting clinical investigations for their devices and you'll be the driving force behind their clinical affairs/ operations activities and as integral part of the team responsible for our success.

Responsibilities:

Develop clinical evaluation strategies and elaborate investigations including authorisation for their devices to monitor their safety and efficacy and to meet regulatory requirements
Perform literature searches/ reviews as necessary to obtain and maintain up to date knowledge for effective clinical evaluations and investigations
Take the lead in conducting and evaluating clinical investigations
Document clinical investigations including study reports, summaries of safety and clinical performance. Develop and update clinical evaluation reports
Manage the quality, accuracy, and timely production of clinical study plans and reports
Support risk management activities like product risk analyses and benefit-risk assessments
Support vigilance case (complaints, incidents) evaluations
Close cooperation with R&D, regulatory affairs, quality management and sales & marketing and with external clinical sites, CRAs, medical advisor, regulatory authorities and notified bodies

Requirements:

University degree in science
At least 3 years of professional experience in leadership / project management of clinical investigations of medical devices
5 years' experience as Clinical Research Associate (CRA) with the ambition to take the next step and become a clinical study manager, or currently employed as a clinical study manager or clinical project manager with previous site monitoring experience
Experience in performing systematic literature searches and in scientific / medical writing
Excellent presentation and moderation skills, including technical editing and QC skills
Good understanding of statistics, together with the ability to interpret complex clinical data
Team oriented, accurate and self-dependent personality with an analytical working style and strong communication skills toward authorities, clinical staff and internal stakeholders
Knowledge of MEDDEV 2.7/1,MEDDEV 2.7/2, MEDDEV 2.12/2, ISO 14155 and MDR requirements to clinical evaluations / clinical investigations
Experience with Risk Management, ISO 14971 and FMEAs is a plus
Excellent command of spoken and written English

This is an office-based position in Berlin. Relocation for the right candidate from across Europe is also an option but you'll need to be based in Berlin for a minimum of 3 or 4 days per week post Covid 19.