Clinical Project Manager with over 18 years of experience in the pharmaceutical and Diagnostics/MedTech industry
In-depth knowledge of all relevant Study Documents, Study Start-up phase (incl. CTIS), CRO selection & management
Currently supporting CRO via K-Recruiting with excellent feedback
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap; full-time; onsite & remote
- Qualification
- Master of Science in Health Management
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Clinical Project Management, International Study Management, Phase I-III, Study Start-up, FDA, EMA, Team Leadership, Budget Management, Vendor Management, Bid Defense Meetings, ICH-GCP Compliance, CTIS, Pharma, Biotech, Medical Device, CRO
Key-Facts
Extract from Previous Activities
CRO Company (via K-Recruiting)
Clinical Project Manager Oncology
Project management for a multicentre clinical trial Communication and coordination with the sponsor
Creation, maintenance and tracking of project plans and timelines
Coordination of internal processes (e.g. CRA, regulatory, monitoring, site management)
Preparation, implementation and follow-up of meetings (internal & external)
Quick familiarisation with customer-specific SOPs and processes
Budget monitoring and support with financial project management
Support with recruitment strategy, including patients with complex access (some hospitalised, some discharged)
Biotechnological Company, Germany
Clinical Project Manager
Clinical Project management: conducting of international, multicentric clinical studies for several phase III vaccine studies.
Sponsor oversight; clinical development oversight; collaboration intensively with our partner
CRO and vendor management
TMF spot-checks
Review of study documents such as study protocols, amendments, informed consent form, clinical study reports
Set-up and maintenance of insurance for all participating countries, injury claim management
Visit report reviews
Participating in international study team meetings and regulatory meetings to discuss submission process to FDA and EMA for registration purposes
Additionally, the preparation and oversight of international audits and inspections (EMA and FDA) were also under my responsibility from Sponsor side within ClinOps team
Pharmaceutical Company, US
Clinical Project Manager Oncology
Oncology study investigating a new IMP
Oversight of 27 study centres in the United States and sites in two European countries (Italy and the UK)
Medical Device Company
Clinical Project Manager Oncology
Oncology study (brain metastases) investigating a new medical device
Oversight of 23 study centres across Western Europe
Pharmaceutical Company
Clinical Research Manager Oncology
Strategic planning and execution of a multicentre phase III clinical study investigating a new IMP for FOP
Oversight of clinical trial conduct across 13 global study sites
Responsibility for project management, CRO and vendor management, team leadership and meetings, budget oversight, and contract negotiations
Design and implementation of a new sub-study for the patient interview process
Support of FDA and EMA submission processes for registration purposes