We're looking for a Preclinical Study Manager, working in the Biotechnology/Medical Devices industry in Boston, Massachusetts, United States.
Manage outsourcing of CMC and preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacokinetic, toxicology, and biodistribution studies.
Work within established contract research organization agreement terms to support preclinical development programs.
Work closely with other functional areas to facilitate planning, development, tracking, and study timelines of CMC and nonclinical outsourced studies.
Participate in selection of CROs including qualification/scientific assessments and tracking vendor performance.
Generate and submit concept Sheets to CROs and obtain competitive bids and timelines and negotiate as appropriate.
The pay we are offering is 130,000 per year.
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
MS degree in Biology/Toxicology preferably DMPK or a related field
5 years relevant experience in the biotechnology/pharmaceutical industry or contract research organization
Working knowledge of invoicing/accounting/contract
Knowledge of global regulatory guidelines (GMP/ICH/GLP/OECD) is a plus
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.