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Job Description:

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 studies

• Serve as subject matter expert (SME) and owner of data management plans

• Oversee 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 teams

• Leads 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 plans

• Leads data review, including query management, and leads activities required for interim and final database locks

• Participate in preparing function for submission readiness and may represent function in a formal inspection or audit

• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents

• Securing and coordinating functional resources to support all studies within scope to ensure delivery for implementing data capture tools, Data processing, coding and validation

• Maintain standard operating procedures (SOPs), process maps and templates and timelines to support operational and oversight models

• May 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 practices

• Ensure the quality of the data in each database delivery, and quality of other data management deliverables

• Provide functional oversight to data management and other clinical trial team members as appropriate

• Champion 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".

Job ID: 1459214BR

Title: Senior Manager, Clinical Data Management - Clinical Trials (Remote)

Company Indicator: Walgreens Boots Alliance

Employment Type:

Job Function: Business Development/Planning

Full Store Address: 108 WILMOT ROAD,DEERFIELD,IL 60015

Full District Office Address: 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-00001-Y

External Basic Qualifications:

• Bachelor’s Degree in pharmaceutical / biotech industry and / or Contract Research Organization (CRO)

• At least 4 years’ experience in Data Management and/or clinical operations in pharmaceutical/biotech/CRO

• 4+ years in a Clinical Data Management leadership role

• Experience in project management and managing data management activities for large drug development programs

• Experience in development of database specifications and build for decentralized clinical trials

• Experience in management of data management activities performed by decentralized trial vendors

• Experience with all phases of development in one or more therapeutic areas

• Experience of data management best practices, standards, library development and maintenance

• Experience with clinical trial documents (protocols, statistical analysis plans, case report forms (CRFs), study reports) and processes

• Experience of broad drug development process with expertise in the interfaces with the data management function

• Strategic knowledge of Food and Drug Administration (FDA) and ICH regulations and industry standards applicable to data capture and data management process

• At least 2 years of experience contributing to financial decisions in the workplace.

• At least 2 years of direct leadership, indirect leadership and/or cross-functional team leadership.

• Willing to travel up to/at least 10% of the time for business purposes (within state and out of state).

Preferred Qualifications:

• Knowledge of relational databases and experience using multiple clinical data management systems

• Experience in the development and management of decentralized clinical trials utilizing direct data capture

• Knowledge of electronic data capture and data warehouse technologies as applied to clinical trials

• Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models

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