Efficiently manage and successfully execute all aspects of global project start-up;
Perform quality checks on submission documents and site essential documents;
Prepare and approve informed consent forms;
Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
Present during bid defenses, general capabilities meetings, and audits.
Qualifications
Bachelor’s degree or Master's/PhD degree within Life Sciences and more than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
Strong oral and written communication skills.
Knowledge of pharmaceutical industry, International Conference on Harmonization guidelines, and FDA or applicable local regulations.
Possess thorough understanding of regulatory submissions activities;
Demonstrated ability to organize, instruct and supervise a team in the completion of multiple tasks/projects;
