We're looking for a Clinical QC Coordinator/Specialist/Manager, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts, United States.
Reviews clinical documents (e.g., manuals, study plans, etc.) for compliance with regulations, regulatory guidelines and SOP's
Supports enhancement of QC systems, as needed, to support clinical operations, medical writing and data management
Writes and reviews Clinical Operation SOP's and provides input during the review of cross-functional SOP review.
Works with QA team, open and reports process deviation from clinical operation procedures and tracks until completion.
Represents GCP clinical project team meetings and other cross-functional meetings and discussions.
The pay range we are offering is 50 to 60 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Life science degree.
Advanced knowledge of ICH-GCP guidelines, FDA clinical research regulations, GDPR and other regulations.
Strong background in clinical operations and quality assurance / compliance in a pharmaceutical company, biotech or CRO setting.
Critical thinker, able to synthesize information from a variety of sources and apply to problem solving.
Ability to manage multiple projects and tasks effectively and be able to shift priorities rapidly in a fast-paced environment.
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.