Anthem, Inc. Lead Clinical Data Manager in Richmond, Virginia
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.
The primary role of the Clinical Data Management Lead is to provide oversight of both the client’s Electronic Data Capture (EDC) system and Database lock per protocol timelines, as well as supporting the design of the electronic Case Report Forms (eCRFs) for HealthCore’s clinical research studies. These type of studies include but are not limited to Pragmatic Clinical Trials (PCTs), Post-Authorization Safety Studies (PASS), and Disease or Product Registries. In addition, this role will support the data collection efforts in study types such as Patient/Provider Surveys, Focus Groups and Medical Record Abstraction studies.
Preferred Locations: Watertown, MA, Wilmigton, DE, or Alexandria, VA HealthCore offices. If you reside within a commutable distance from an Anthem office as well, please apply!
Please note the true title at hire will be Research Data Manager Lead-HC
Represents the data management functions in client-facing and internal meetings.
Provides data management input to proposals and protocols.
Contributes to budget content and lead initial budget build of the data management scope.
Develops and manages timelines for key data management deliverables in coordination with the various area functional leads.
Monitors vendor performance to ensure timelines and data quality standards are met.
Reviews and approves key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.
Reviews final versions of survey materials and medical record abstraction data collection forms for completeness and quality.
Performs UAT on all data collection mechanisms.
Oversees all data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing data to ensure completeness, accuracy and consistency of all databases.
Develops or updates clinical data management Processes, Guidelines and Standard Operating Procedures (SOPs).
Provides mentoring and training to Data Management staff.
Acts as escalation point for issues arising from site startup data collection through database lock.
Assigns Data Associates to studies and sites based on experience, geographic location, and time coverage.
Regularly review metrics reports to ensure quality and timeliness with the scope of work, and identify out of scope activities.
Monitors overall study progress daily/weekly and proactively develops or adjusts plans as needed to achieve targets.
Assist with clinical database audits and provide subject matter expertise to internal and external organizations reviewing/auditing clinical data management to ensure integrity and quality of clinical data.
Sound understanding of pertinent regulations such as ICH-GCP guidelines and 21CFR11.
Leads the data management activities for retrospective and prospective research projects that include, but not limited to, development and management of data collection and abstraction processes for medical chart abstraction and survey research to collect information from physicians and patients for HealthCore clients.
Coordinates and participates in the development and design of questionnaires used to conduct patient and physician surveys as well as case report forms (CRFs/eCRFs) used for medical chart abstraction and research data collected by investigative sites.
Manage and coordinate data collection and management activities for assigned research projects.
Develop standard operating procedures and monitor and conduct reviews to ensure compliance with policies, procedures, client specifications, contractual scope of work and regulatory agency guidelines. Leads process for identifying, selecting and contracting third party service providers as needed for medical chart abstraction or survey conduct
Requires BA/BS in Life Sciences, Epidemiology, Sociology, Nursing, Pharmacy or related field; 5 years research experience with at least 3 years of experience in leading and managing data management projects; or any combination of education and experience, which would provide an equivalent background.. 7+ years of CDM Experience including Data Management Leadership and Late Phase Research experience. Thrives in a collaborative environment but works well autonomously. Excellent oral and written communication, skills are essential. Effective time management and the ability to work on multiple and varied tasks is important. Proven project management experience is required. Strong computer skills, including: MS Excel, MS Word, and MS PowerPoint. A solid understanding of late phase data management and how functions such as health economics, outcomes research, and epidemiology play a role in these studies. Previous experience with claims data and clams databases is a plus.
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.
Anthem, Inc. has been named as a Fortune 100 Best Companies to Work For®, is ranked as one of the 2020 World’s Most Admired Companies among health insurers by Fortune magazine, and a 2020 America’s 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.