Expert for Clinical Affairs and Clinical Trial Management with more than 20 years of experience with medical devices and pharmaceuticals studies
Strong expertise in planning and preparing clinical assessments according to MDR and MEDDEV
Supports clients in Clinical Affairs with strategic/Project management related tasks but also with hands-on tasks like SOPs and Clinical Documentation acc. to GC
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Biology, PhD
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Clinical Affairs, Clinical Trial Management, Clinical Project Management, Clinical Assessments, Clinical Strategies, Clinical Documentation, GAP Analysis, Literature Research, MDD/MDR, MEDDEV, GCP, Medical Devices & Pharma
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Interim Project Lead Clinical Trials
Strategic Clinical Trial Program Management
Coordination of interfaces of all clinical tasks assigned to the project
Planning and execution of global clinical studies per laws, regulations, and Good Clinical Practice
Planning and preparing clinical assessments according to MDR, MEDDEV 2.7/1 revision 4
International presentations of Scientific and Medical Data at Congresses/Conferences
Medical Device Company, Austria
Clinical Study/Affairs Manager
Development and execution of all study associated documentation including protocols, contracts, and reports
Reviewing source documents, case report forms, and data for accuracy; ensuring timely submission & storage
Responsible for clinical study data entry and audit
Coordinating study site preparation, equipment, and training, ensuring compliance to the investigational plan
Planning and fulfillment of activities on medical devices in Post Market Clinical Follow-Up and Surveillance
Coordinating meetings and communications between investigators and organization
Medical Device Company, Germany
Manager Clinical Affairs
Managing Global Clinical Study Programmes
Definition and implementation of clinical strategies for approvals in EU and non-EU countries
Planning and execution of global clinical studies per laws, regulations, and Good Clinical Practice
Developing SOPs, clinical documents and policies for clinical study management and safety reporting
Planning and fulfillment of activities on medical devices in Post Market Clinical Follow-Up and Surveillance
Generating and supporting the publication of papers, posters and presentations in relevant medical and scientific journals and conferences
Diagnostics Company, Germany
Advisor Clinical Affairs
Design, planning and conduct of IVD clinical study
Implement clinical study projects through coordinated internal and external activities
Planning and preparing of clinical assessments
Gap analyses considering regulatory requirements
Literature searches
Creation of harmonized Standard Operation Procedures and Work Instructions
Development and execution of all study associated documentation including protocols, contracts, & report
Coordinate study site preparation, equipment and training
Pharmaceutical Company, Austria
Clinical Project Manager
Managing all Global Clinical Trials
Responsible for Clinical Trial Regulatory Submissions
Day to Day Global Clinical Project Management of Clinical Trials and Post Marketing Surveillance studies
Editing of SOPs, CAPA and Change Controls