Principal Clinical Data Manger

Overview Manage and lead all aspects of data management activities for clinical studies in compliance with ICH/Good Clinical Practices (GCP) for a fortune 200 company with some of the most iconic brands! Have a bachelor's degree with eight years’ experience in clinical data management? If so, we want to speak with you! We are actively recruiting for a Principal Clinical Data Manger to join our team in Richmond, VA, or we are open to remote work arrangements. What you’ll be doing: • Manage and lead all data management (DM) activities for clinical studies including data management plans, electronic data capture (EDC) system design and build, user acceptance testing (UAT), clinical trial data review and database cleaning, and database lock to ensure completeness, accuracy, and consistency of clinical trial databases in compliance to ICH/GCP. Ensures all DM activities are performed in an accurate and timely manner. • Oversee CRO data management activities including EDC database specification process and training of study site personnel on data entry requirements. • Assist with development of Case Report Form (CRF) following ALCS data standards and Edit Check Specifications, ensuring adherence to industry standards (CDISC/CDASH) • Maintain all the necessary documentation to support the accuracy and integrity of clinical databases. Ensure the Trial Master File documentation is complete. • Participate in cross functional team meetings and communicate with all departments regarding project statuses/issues • Manage EDC system user administration and assist with resolving issues with access. • Contribute to quality enhancement of clinical data management including SOPs and work instructions. • Proactively identify potential study issues/risks and recommends/implements solutions. What we want you to have: • Bachelor’s degree in science or related field. • 8+ years of experience in clinical data management. • Experience using and programming (study build) in the Medrio EDC system or another EDC system is highly preferred. At a minimum, a working knowledge of SQL or SAS. • Experience in CRO oversight to ensure vendors deliver the work within agreed timelines. Experience working with CRO’s to design and develop all data management study documents as well as review of data transfers in SDTM format per ALCS specifications. • Knowledge of and experience in clinical research, Good Clinical Practices, ICH guidelines and FDA regulations as applicable to clinical data management; experience with pharmaceutical and/or medical device companies is a plus. • Knowledge of medical and clinical terminology and adverse event coding such as MedDRA • Working knowledge of CDASH/CDISC standards is preferred In addition to the opportunity to apply and develop your skills toward key business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package. Company Overview Altria has a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. Altria’s Vision through 2030 is to responsibly lead the transition of adult smokers to a non-combustible future. Altria is Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, Altria’s businesses and society. Altria’s wholly owned subsidiaries include the most profitable tobacco companies in their categories: Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), and John Middleton Co. (Middleton). Altria’s smoke-free portfolio includes Helix Innovations LLC (Helix), the maker of on! oral nicotine pouches, exclusive U.S. commercialization rights to the IQOS Tobacco Heating System®* and Marlboro HeatSticks®*, and an equity investment in JUUL Labs, Inc. (JUUL). Altria also owns equity investments in Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company. At Altria, we celebrate the power of diverse teams working together to shape our future. We are inspired to bring our best because our unique strengths are valued. We believe our personal success and progress should be guided by Our Cultural Aspiration, a new articulation of what we value and who we aspire to be, collectively. Our Cultural Aspiration respects and complements individual identity, embracing each other’s unique strengths, welcoming newcomers and developing the best, most inclusive and diverse teams. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer. Learn more about Altria at www.altria.com and follow us on Twitter, Facebook and LinkedIn. *IQOS Devices and HeatSticks® are currently unavailable for sale in the United States.