Job Summary:

Responsible for timely and high-quality data management deliverables supporting Walgreen Clinical Trials studies. Responsible for conducting oversight of Data Management activities to ensure they meet obligations as described in International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and project Scope of Work. Provide data management expertise and capability in support of submission studies as well as post-marketing registration and non-registration studies.

Job Responsibility:Lead data management activities for customer studiesServe as subject matter expert (SME) and owner of data management plansOversee creation and maintenance of study databases including industry standard Electronic Data Capture (EDC) systems including Medidata Rave, Veeva Vault EDC, Viedoc, etc.Provide input to functional governance with Walgreens vendors. Partner with appropriate team members to resolves issues escalated from the vendor and teamsLeads clinical trial data collection set-up, data review, and database lock as follows:Works with vendors to complete set up of EDC and other study data collection tools such as eSource, Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA).Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, serious adverse event (SAE) reconciliation guidelines, database lock plansLeads data review, including query management, and leads activities required for interim and final database locksParticipate in preparing function for submission readiness and may represent function in a formal inspection or auditEnsure archival and inspection readiness of all Data Management Trial Master File (TMF) documentsSecuring and coordinating functional resources to support all studies within scope to ensure delivery for implementing data capture tools, Data processing, coding and validationMaintain standard operating procedures (SOPs), process maps and templates and timelines to support operational and oversight modelsMay prepare metrics to support the function's key performance indicators (KPIs)Represent function in external professional projects and organizations such as Society for Clinical Data Management (SCDM), Clinical Data Interchange Standards Consortium (CDISC), Drug Information Association (DIA) to identify industry best practicesEnsure the quality of the data in each database delivery, and quality of other data management deliverablesProvide functional oversight to data management and other clinical trial team members as appropriateChampion and adopt technology improvements and tools for use in clinical data management processes“About Walgreens and WBA
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170-year heritage of caring for communities. WBA’s purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation’s medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide.”
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".