OBG is announcing vacancy of Clinical Study Specialist for our partner, worldwide leading pharmaceutical company The candidate should meet the following requirements as to qualification and experience:
- University degree in Medical/Pharmaceutical
- Experience of work as Monitor is a must; experience in sites selection process, start-up and activation of sites is an advantage
- English at upper-intermediate level as minimum
- Good negotiation and organization skills, including ability of collaborating with other departments, sites
- Knowledge of local legislation, including knowledge of start-up process in Ukraine, insurance requirements, options to supply patients with medications
- Experience in local ICF customization
- Experience in contracts and budget negotiation.
- Understanding of third-party vendors oversight (import, local purchases) is an advantage.
- Site selection (including coordination of questionnaires completion, phone contacts, on-site visits as needed within defined timelines)
- Discussion of Investigator grant (including managing of difficult situations, convincing Investigators), prepare and negotiate contract and ensure its signatory by all parties for Institutions/ Investigators/ Diagnostic centers, including any addendums (if needed)
- Coordination of local Insurance issue process
- Local ICF customization process
- Coordinate of Third-Part Vendors' work in regards to logistic activities - i.e. local purchase, import etc. -coordination and ensuring timely payments to Institutions/ Investigators/ Diagnostic Centers
- Regular communication with Local Study Team, including consulting on topics related to local peculiarities in Clinical trials conduct