Clinical Project Management Expert

Your challenge

Responsibility

• Obtaining offers/requests for proposals (CRO, consultant, etc.) and awarding cooperation projects with external partners
• Management/coordination of clinical performance evaluations (external studies)
• Support in the definition of product requirements
• Creation of relevant documents for D7329000
• Preparation of technical documentation in accordance with P4723100
• Contact with authorities and implementation of authority notifications and ethics committee in compliance with national laws and guidelines
• Preparation of study documents (e.g. study plans, study reports, laboratory manuals)
• Creation of confirmations for country registrations and customer feedback
• Review of study documents (e.g. study plans, study reports, laboratory manuals)
• Review of confirmations for country registrations and customer feedback
• Review of technical documentation in accordance with P4723100
• Budget and investment planning
• Communication with key opinion leaders, consultants, CRO, suppliers
• Review of incoming invoices/overview of costs in the context of clinical performance evaluations
  
  

Your Profile

Job Requirements

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

Good knowledge of FDA requirements related to IVDs and MDs, ISO regulations and CLSI guidelines are a must

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 communication skills are a must

Excellent presentation and diplomacy skills, with the ability to negotiate and resolve conflicts.

Desirable Requirements Communication and negotiation skills

Expected travel time <10% (location-dependent)

Driving license

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.