Address
Form of workDescription
We're looking for a Sr. Associate, Clinical Trial Management, working in Pharmaceuticals and Medical Products industry in 2525 Dupont Drive, Irvine, California, 92612, United States.Job description:
- Assists the CTM/OSL and FACT team with regional study feasibility, the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.
- Assists the CTM/OSL in region-specific document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They assist in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.
- Assists the CTM/OSL in regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; and ensuring adverse event reporting.
