We're looking for a Clinical Trials Manager, working in the Biotechnology/Medical Devices industry in Seattle, Washington, United States.
Conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
Assures site compliance with the routine protocol and regulatory requirements and quality of data.
Assists in the setting and updating of study timelines.
Assists in CRO or vendor selection.
Coordinates CROs or vendors.
Drafts and coordinates review of protocols, informed consents, case report forms, and monitoring plans.
Assists in the review of routine data and preparation of safety, interim, final study reports, and resolution of data discrepancies.
Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
Participates in abstract presentations, oral presentations and manuscript development.
Interfaces with individuals in other functional areas to address routine study issues.
Assists in the training of Clinical Research Associates and Clinical Project Assistants.
Participates in two or more departmental or interdepartmental strategic initiatives.
The pay range we are offering is 51 to 56 per hour. This position may present an opportunity to go permanent.
Our client is a people driven staffing company. Growing fast - 33% annually!
How? Building trusting relationships with top candidates. Like you! You’ll get one-on-one time focused on your skills, needs, and discovering opportunities in which you’ll thrive. The goal is to place you in the right position for you and your goals.
Where? Top IT and telecommunications companies. You’ll make a difference and grow in Technology, Government Services, Professional Services, or Engineering.
Helping you achieve your goals! It’s the right way and the only way to succeed in staffing.
Experience Required for Your Success
Must be willing to travel to different sites
Working knowledge and experience with Word, PowerPoint and Excel
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
Ability to develop tools and processes that increase measured efficiencies of the project
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
Must have a general understanding of functional issues and routine project goals from an organizational perspective
Excellent verbal, written, interpersonal and presentation skills are required
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.