Clinical Trial Lead (m/w)
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Clinical Research organization, based in Germany.
The company is a global CRO.
I am currently looking for Clinical Trial Lead (m/w) for studies in the field of Oncology.
· Responsible for study set up, from kick off meeting to planning of sites and patients allocation
· Work in close collaboration with monitoring teams, providing continuous training and support about all study related information ( devices, monitoring plans, documents, processes, protocols etc.)
· Supervision of the study AED at a regional and national scale, optimization of budgets
· Preparation of documents for submission process
· Implementation of IT systems and ensure distribution of IMP, non IMP and all study related equipment to all sites
· Coordination of all monitoring activities, ensure realization according to quality standards, timeline and budget
· Supervise data collection and Pharmacovigilance and material management
· Continuous budget review and realization of monthly progress reports
· Preparation of audits and inspection reports and as well application of the recommendations
· Ensure timely database lock and study closure visits
· Oversee statistical analysis, archiving and reporting according to timelines
· Degree in Life Sciences
· In depth knowledge of the ICH Guidelines and GCP with understanding of regulatory requirements in DACH, EU and/ or CEE countries.
· Understanding of the global drug development process experience
· Several years of experience as SCRA or CPM in a CRO or within the pharma industry, ability to understand the issues and processes related to study monitoring and reporting, risk management and all associated documentation
· Leadership skills and ability to train and coach junior team
· Proven organizational skills and ability to work under (time) pressure
· Proficiency in German and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ann-Kathrin Zeisberger.