Hours per week:
Our client is looking for a candidate ideally local to Boston onsite 1-2 days a week (Tuesdays and Wednesdays) to be the Clinical QA support for mid/late stage oncology studies. The perfect candidate will have 10 years of small biotech experience in outsourced companies using CROs with oncology experience. Ideally this person will be tasked with issues around vendor oversight for clinical trials, help prep for FDA inspections, participate in FDA inspections, and train people for FDA inspections, and have fit for purpose approach to quality. Pluses would be biomarker experience and biospecimens. 10 years of clinical quality experience is required and experience of being assigned clinical trial teams to partner with who meet with CTM’s regularly to talk about issues and helped with compliance and regulatory issues and helped preform clinical audits.
Hybrid, MA: Sr. Clinical Quality Professional (234140)