Title: Nonclinical Study Management and Operations Specialist
Location: Cambridge, MA
Schedule: M-F Full Time
Target Start Date: ASAP
Provide planning, coordination and execution of nonclinical safety assessment and Drug Metabolism and Pharmacokinetics DMPK activities that support drug discovery and drug development programs across therapeutic areas.
Primary responsibility for Contract Research Organization (CRO) vendor management, including CRO technical evaluation, contract development, and contract management.
Assist project representatives in nonclinical study start-up and maintenance activities.
Specific tasks include communicating with contract research organizations (CROs) for quotes, facilitating contracts, compound management, coordinating and tracking sample shipments/receipt, verifying invoices, SEND data set coordination, monitoring studies, CRO site visits, reviewing documents (protocols, reports) and maintaining file systems for accuracy and completeness.
Assist pathologists in maintaining the site pathology function and completing pathology studies. Specific duties include slide specimen management (receipt, inventory, return), slide scanning and document management.
Assist in Departments’ finance/contracts/SOWs processes, specific duties include drafting budgets and reforecasts.
Provide administrative assistance by arranging/executing domestic and international shipments and associated paperwork, coordinating and tracking archive requests, coordinating/planning/recording events, meetings and visitor schedules, and reviewing and processing documents.
- Toxicology/Drug Metabolism and Pharmacokinetics DMPK in vivo research experience, direct experience managing or monitoring studies highly desirable
- Basic understanding/familiarity with pathology phase of studies and quality control QC procedures
- Excellent communication, negotiation and organizational skills
- Bachelors of Science with study in a field related to biomedical research (ex pharmacology, toxicology etc)
- Minimum of 4 years of relevant work experience in the pharmaceutical/biotech industry or at a CRO.
- Experience in design and execution of in vivo studies is highly desirable.
- Basic knowledge of the drug development process, and SEND and GLP requirements for nonclinical studies a plus.
- Intermediate to advanced proficiency using Microsoft Word, PowerPoint and Excel
- Ability to travel within North America up to approximately 10% (CROs) and availability for occasional early morning and evening virtual meetings is required.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.