Mgr Clinical Quality Assurance-PS9137
NERI, recently acquired by HealthCore, Inc., a health services research firm, headquartered in Wilmington, DE. Founded in 1996, and now an independently –operating subsidiary of Anthem, Inc., Healthcore/NERI provides care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. Healthcore’s projects range from retrospective to large scale, prospective studies in the areas of drug, vaccine , and medical devices safety surveillance, risk management, pharmacoepidmeology, health outcomes, pharmacoeconmomics, and comparative effectiveness research.
New England Research Institutes (NERI) was founded in 1986 and has grown to become a contract research organization(CRO) with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management (Phase I-V), epidemiology, and state of the art media and dissemination research.
This position must be located in Watertown, MA and is not remote.
Responsible for managing the day-to-day activities of one or more clinical quality assurance (QA) program components which may be related to clinical trials reporting, ICH guidelines, federal and/or international clinical trial regulations and/or other quality assurance related activities.. Primary duties may include, but are not limited to: Implements and evaluates current processes including standard operating procedures (SOPs) and process improvement initiatives. Provides oversight in the planning, implementation and coordination of clinical trial. Participates in internal and external quality review/audit activities. Manages and oversees quality assurance activities, which may include, but is not limited to: managing the production, analysis, and submission of reports to management; coordinating audit activities (internal as well as client and regulatory authority audits and FDA biomedical monitoring inspections); managing achievement and maintenance of Quality Systems Manual (QSM), Standard Operating Procedures (SOPs), policies, and associated trainings; conducting internal QA audits, support investigative site or vendor audits, and providing consultation to business units and team leads for SOP and regulatory compliance. Hires, trains, coaches, counsels, and evaluates performance of direct reports.
BS/BA and a minimum of 3 years of relevant experience in clinical quality assurance required.
•In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs, GCP, and FDA
•Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills
•Ability to work independently and to work interactively with multidisciplinary teams to facilitate results.
•3+ years of relevant experience in CQA
•Technical knowledge to manage quality assurance oversight for clinical supply.
•Supervisory experience preferred.
In addition to a dynamic work environment, Healthcore offers a competitive salary and a comprehensive benefits program including a 401(K) plan; health, dental and vision insurance; discounted fitness club membership; life, AD&D, short and long term disability insurance coverage, tuition assistance, an employee stock purchase plan and free parking. As an independently operating subsidiary of Anthem, Healthcore offers the resources of the nations’ leading health benefits company in a small company environment.
An Equal Opportunity Employer/Disability/Veteran