...client’s issue/problem is feasible. If the study is feasible, proposes the study design, develops the proposal and budget, and as required acts as consultant to or provides project management for the implementation and conduct of the study, including protocol writing...
...Mentors less experienced members of the team.
6. Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to:
a) Assignment of resources and timelines; reorganization of daily...
...completed site activation, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required.
- Assumes accountability on SSU deliverables including, but not limited to:
Life cycle maintenance amendment...
• Previous experience in clinical research including submissions experience
• Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally....
17 дней назад
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