Project Manager I, Regulatory & Scientific Affairs

Join The CTI Team•Covington, KY

2d•Hybrid

About The Position

Primarily responsible for overseeing and coordinating the operational aspects of safety/data monitoring committee projects ensuring quality, timeliness and client satisfaction and will manage all phases of additional client projects from planning to completion. In conjunction with RSA Directors and Medical Writers, specific tasks or duties may include, with anticipated oversight from Manager, RSA: Plan: Create timelines and project needs assessments Coordinate: Organize resources to develop the project, including multifunctional project team, budget, external vendors, etc.; manage timelines Implement: Produce or oversee timely production of quality deliverable, on budget Problem Solve: Identify challenges that arise and propose effective solutions Finalize for Client/Senior Management: Oversight of final review and production of deliverables Provide project status reports to client and management Prioritize and manage resources to meet needs of several clients simultaneously with main project load expected in resident region Lead internal or external meetings with anticipated oversight from Manager, RSA Effective communication and professional interaction with client and internal team ensuring client’s expectations are met.

Requirements

Bachelor’s degree in allied health field such as nursing, pharmacy, or health/natural science or an equivalent combination of education and relevant work experience.
At least 3 years clinical or business background in drug or device research/development, biotechnology, pharmaceutical or clinical research and/or combination of education & experience
Experience with drug development process and/or medical writing preferred

Responsibilities

Create timelines and project needs assessments
Organize resources to develop the project, including multifunctional project team, budget, external vendors, etc.; manage timelines
Produce or oversee timely production of quality deliverable, on budget
Identify challenges that arise and propose effective solutions
Oversight of final review and production of deliverables
Provide project status reports to client and management
Prioritize and manage resources to meet needs of several clients simultaneously with main project load expected in resident region
Lead internal or external meetings with anticipated oversight from Manager, RSA
Effective communication and professional interaction with client and internal team ensuring client’s expectations are met