The Associate Clinical Project Manager assists with the execution of the coordination of activities associated with the set-up, management and closure of clinical studies and is responsible for the successful completion of studies on schedule and within budget.
1. Assists with the generation of the clinical development plan.
2. Coordinates the execution of assigned studies from conception through study closure and final inspection preparation.
3. Participates in the development and review of study documents (i.e. protocol, ICF template, plans, manuals, site recruitment materials, CSRs, etc.).
4. Assists with vendor identification, selection and management activities in collaboration with department leadership.
5. Maintains task ownership matrix to ensure internal and external stakeholders are aligned on assigned responsibilities.
6. Assists with the development and maintenance of study timelines and budget; also ensures study is appropriately resourced.
7. Provides study training for all study team members and ensures training is documented.
8. Documents study specific decisions, actions, issues and risks information throughout the lifecycle of the study.
9. May represent clinical operations at project team and other cross-functional meetings.
10. May conduct quality oversight and site engagement visits.