Clinical Project Manager

Clinical Project Manager

Remote – Office in San Diego

Overview: My client is an Early Phase and Phase 1 CRO that is looking for a Clinical Project Manager to be the main interface between the company and the clients. This CPM must have years of experience as a CPM at a CRO.

The Company: My client is a smaller CRO in San Diego that focuses in Endocrinology, Diabetes, Metabolic, and NASH. Built on 15 years of experience and more than 280 metabolic clinical projects conducted, this company provides customized clinical research services for multinational, early development clinical trial programs designed to give our clients an advantage in today’s rapidly evolving landscape of metabolic drug and device development.

The CPM will be responsible for:

- Preforming Protocol reviews

- Create and approve study documentation such as consent templates, project plans, case report forms, and monitoring plans and reports.

- Coordinates requirements for third-party vendors and oversees vendor performance.

- Site Initiation Visit training materials 

- Prepared for, participated in, and reviewed client and internal audits

- Built an eTMF and strong knowledge of working with eTMF's 

- Creation of study timelines and proposal development 

- Site identification, feasibility, selection, qualification, and drug supply management 

- Good understanding of GCP, ICH guidelines, and FDA, IRB/ IEC regulations 

Requirements:

- Bachelor's degree in biological sciences or related fields 

- 2+ years in project management 

- CRA experience

Certifications: 

- Project management certification (or willing to obtain) 

- MBA is a plus