Do you want to move up in your career and start within an international pharma company, leader on the market?
If you want to be part of a globally acting sponsor working in an international team we offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.
If you are a SSU, a Senior CRA or have relevant experience in the field of clinical studies this position can be the next step for you!
Our Client offers home based and office based positions for Study Start-up.
Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes, where applicable, to support clinical research
Prepare the initial country/site study level ICFs, as well as revisions as a result of protocol amendments, risk profile updates, etc. Contribute to the country specific ICF template review
Coordinate translation process for all required trial documents and oversee the quality of final documents
Prepare study-specific Clinical Trial Agreements templates with investigators and institutions
Negotiate contracts with Institutions and investigators partnering with regional and global functions to process requests outside of previously agreed parameters
Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times
Negotiate budget costs and contract language with the appropriate party at the sites
Work with sponsor in cases where budget exceptions present themselves
Assist project teams with site selection activities as required
Maintain open communication and participate in regular meetings/teleconferences with Sponsor
Review study documents as required, e.g., patient directed materials
Demonstrated ability to work with multiple study sites in several therapeutic areas