Anthem, Inc. Clinical Research Quality Assurance Manager in Wilmington, Delaware
SHIFT: Day Job
Your Talent. Our Vision. At HealthCore, Inc. , an independently-operating subsidiary of Anthem, Inc. and a health services research firm, it’s a powerful combination. It’s the foundation upon which we’re creating greater access to care for our members, greater value for our customers and greater health for our communities. Join us and together we will drive the future of health care.
Preferred location is Watertown, MA but can be in any Anthem office location.
Responsible for serving as a liaison with and overseeing the quality assurance activities/projects/programs for HealthCore.
Primary duties may include, but are not limited to:
Leads quality strategy meetings, develops a quality plan, and ensures integration of quality into the overall business process.
Develops performance improvement plans and oversees the clinical quality improvement activities/projects to improve in accordance with HealthCore’s Quality Management System.
Responsible for approving quality record review such as investigations, CAPAs, Change Controls and other quality documents as required.
Assures compliance with corporate QI work plans.
Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results.
Oversees the implementation of new initiatives. Manages interactions with regulators or oversight entities.
Adopt and implement the Quality Management Plan within the scope of the assignment, this will include:
Planning and executing the Quality Management activities.
Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the business to enhance effectiveness.;
Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
Provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
Prepare periodic reports to leadership on quality, risk assessments and specific quality improvement initiatives.
Requires a BS in health administration, nursing, or a related clinical field; 4 years of experience in a Clinical Research Organization or any combination of education and experience, which would provide an equivalent background.
Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
Good organizational, interpersonal and communication skills.
Good judgement and decision-making skills.
Strong influencing and negotiation skills.
Ability to motivate a clinical team.
Anthem, Inc. is ranked as one of America’s Most Admired Companies among health insurers by Fortune magazine and has been named a 2019 Best Employers for Diversity by Forbes. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran. Anthem promotes the delivery of services in a culturally competent manner and considers cultural competency when evaluating applicants for all Anthem positions.