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Elevance Health Clinical Research Quality Assurance Manager in Indianapolis, Indiana

Clinical Research Quality Assurance Manager + Location: National +50 Miles away from nearest PulsePoint, National +50 Miles away from nearest PulsePoint + Job Family: QLT > Clinical Quality + Type: Full time + Date Posted:Jun 23, 2022 + Req #: PS73458 Description Job Description:External Responsible for serving as a liaison with and overseeing the quality assurance activities/projects/programs for HealthCore. Responsibilities include: + 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. Qualifications: External + 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. Please be advised that Elevance Health only accepts resumes from agencies that have a signed agreement with Elevance Health. Accordingly, Elevance Health is not obligated to pay referral fees to any agency that is not a party to an agreement with Elevance Health. Thus, any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Be part of an Extraordinary Team Elevance Health is a health company dedicated to improving lives and communities – and making healthcare simpler. Previously known as Anthem, Inc., we have evolved into a company focused on whole health and updated our name to better reflect the direction the company is heading. We are looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. You will thrive in a complex and collaborative environment where you take action and ownership to solve problems and lead change. Do you want to be part of a larger purpose and an evolving, high-performance culture that empowers you to make an impact? We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates to become vaccinated against COVID-19. If you are not vaccinated, your offer will be rescinded unless you provide – and Elevance Health approves – a valid religious or medical explanation as to why you are not able to get vaccinated that Elevance Health is able to reasonably accommodate. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health has been named as a Fortune Great Place To Work in 2021, is ranked as one of the 2021 World’s Most Admired Companies among health insurers by Fortune magazine, and a Top 20 Fortune 500 Companies on Diversity and Inclusion. To learn more about our company and apply, please visit us at careers.ElevanceHealthinc.com. Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contactability@icareerhelp.comfor assistance. EEO is the LawEqual Opportunity Employer / Disability / Veteran Please use the links below to review statements of protection from discrimination under Federal law for job applicants and employees. + EEO Policy Statement + EEO is the Law Postero + EEO Poster Supplement-English Version + Pay Transparency + Privacy Notice for California Residents Elevance Health, Inc. is an E-verify Employer Need Assistance?Email us (elevancehealth@icareerhelp.com) or call 1-877-204-7664

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