We are currently looking for a Clinical Trial Educator (CTE), being located in Germany. In this position, you will report to the CTE Team Lead and will be part of the global Clinical Operations team. The CTE is responsible for supporting Vifor-sponsored clinical trials, through CRO oversight and interaction with investigational sites, within the assigned countries/territory. You will contribute to and support successful execution of clinical trial protocols and work as a cross-functional matrix team member. Your tasks will include, but not be limited to, the following:
- Establish relationship with investigational sites and act as sponsor interface
- Champion site specific recruitment plan and strategies, mitigate barriers to patient recruitment with stakeholders
- Interact with Vifor Pharma’s global Clinical Study Team, Vifor Pharma’s local medical staff, external Service Providers, and investigational site staff (including investigators and study coordinators) to assist with timely, efficient and high quality trial delivery throughout all stages of the study
- Support operational excellence of global clinical trials through CRO oversight activities, including but not limited to accompanied visits, monitoring report review, tracking of trial related metrics and input to respective project plans
- Ad-hoc member of the global Clinical Study Team
- Provide input into department SOPs and processes, and involvement into investigational site inspection and audit readiness activities
For this role we are looking for a flexible and efficient person bringing the following profile:
- Relevant University Degree (BSc) or Health Care Degree (e.g. RN) with a higher degree (e.g. PhD, MD, PharmD) being preferred
- Minimum of 5 years in the pharmaceutical industry, in a Senior Clinical Research Associate (CRA) or Lead CRA role, including direct contact with study sites and KOLs
- Good understanding of the drug development process and clinical trial execution
- Familiar with clinical trial documentation and regulatory requirements
- Excellent knowledge of ICH GCP requirements
- Excellent user of Office Programs (Word, Excel, PowerPoint)
- Fluency in German and English
- Fluency in Polish is a plus
- Willingness to travel (65% local and international travel required)
You bring excellent verbal and written communication and presentation skills. You are able to interact professionally and productively and to convince others. You are able to coordinate and complete activities across multiple functions. You are a team player, working well in cross-functional teams, but also being able to work independently, and execute tasks with minimal oversight. You take a thorough approach with high attention to detail and display strong organisational and time management skills. You have high ethical standards and integrity.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The companys goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.
The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are