Are you a medical device professional looking for a fast paced, high energy role? Our client has an amazing opportunity for a Clinical Project Manager with medical device experience located in Irvine, California. This company has a great team environment and great leadership that believes in developing their employees for growth to the next career level.
- Supports the selection of clinical study vendors and clinical sites
- Managing operating procedures, and all applicable regulations and guidelines
- Preparing/assisting in the preparation of regulatory documents
- Working with the Legal team to facilitate preparation of clinical trial agreements
- Oversee the collection, review, maintenance and reconciliation of study documents, including site regulatory documents and study subject medical records
- Facilitating/supporting training of and communication with study sites/sub-sites
- Reporting, tracking, and interpreting study data, enrollment trends, and other metrics
- Oversee data review and clarification process
- Providing regular study status reports to management and internal business partners
- Proactively identifies risks and risk mitigation plans
- Attending study investigator/coordinator meetings, offsite study meetings, and other professional conferences as needed to support study startup and enrollment
- Directing Clinical Research Associates, Clinical Research Coordinators, and administrative personnel as needed to support the above activities
- Bacehlor's Degree in related field
- Three (3) to six (6) years of direct clinical research project management experience in the medical device industry
- Experience in project management
- Solid computer skills (i.e. MS Word, Excel, PowerPoint, Project and Outlook)
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.