Clinical Project Assistant (m/w/d)

Über CTI Clinical Trial & Consulting Service Europe GmbH

The origin of the name
CTI was founded more than 22 years ago as the "Cincinnati Transplant Institute." Within a year, it was clear that name didn't encompass our rapidly-growing expertise in adjacent therapeutic areas, like immunology, rare disease, and pediatric programs. The name was quickly changed to "CTI Clinical Trial & Consulting."

Consistent, significant growth
Now in our 3rd decade, CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.

What You’ll Do

· Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project;
· Provide support for site management activities to Clinical Project Manager / Director and CRA
· Maintain clinical project documents in paper and/or electronic Trial Master Files and perform TMF reconciliation and period review follow-up
· Prepare Investigator Site Files
· Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications and plans; distribute reports and communications to sites, vendors, Sponsors, and internal team members
· Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings
· Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management
· Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities

What you bring

· General knowledge of medical and pharmaceutical terminology
· General knowledge of the drug development and clinical trial process
· General knowledge of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements
· Strong verbal and written communication skills in German and English
· Strong organizational and record retention skills
· Strong customer service and interpersonal skills
· Ability to successfully work within a team-based environment
· Ability to work independently with minimal oversight
· Proven ability to handle multiple tasks and manage time efficiently
· Strong computer literacy and proficient with Microsoft Office Suite
· Ability to quickly learn and adapt to new systems and technologies

Why CTI?

• We support career progression
• We believe in promoting from within and we have a structured mentoring program and program for recent graduates
• We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We support a work-life balance and the importance of time with family by offering generous vacation and a hybrid work schedule
• We've received multiple awards recognizing us as one of the best places to work in the industry
• We think globally, but act locally – With employees across 60 countries, we have global reach but maintain culture and connections
• We have had a consistent double-digit growth rate over the last decade
• We invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us

To the Application:

Our job offer Clinical Project Assistant (m/w/d) sounds interesting? Then we are looking forward to receiving your application via: https://cti-clinical-trial-consulting-service-europe.workwise.io/s/YDz88po-clinical-project-assistant-mwd