Senior Site Quality & Training Manager, RWE Clinical Trials

Job Description

Job Summary:

The Senior Site Quality and Training Manager will lead and oversee site-level quality management activities with a focus on integrating cutting edge quality management techniques. This role ensures the safety, rights, and well being of clinical trial participants, the integrity of study data, and the compliance of
essential documents across all Walgreens clinical trial site services. The position is pivotal in implementing risk based quality management (RBQM), quality by design (QbD), and centralized monitoring strategies to support a culture of excellence in clinical research.

Job Responsibilities:

• Oversee site quality control (QC) activities using a risk based quality management (RBQM) approach.
• Use data analytics, centralized monitoring, and statistical sampling techniques to perform QC of trial data, ensuring timely identification and resolution of quality issues.
• Implement quality by design (QbD) principles in collaboration with study teams to embed quality into the study design and processes.
• Participate in initial and ongoing risk assessments to identify critical risk factors in clinical trials and develop proactive strategies to mitigate them.
• Develop, track, and report site level quality metrics to monitor the effectiveness of quality management processes.
• Use metrics to drive continuous improvement initiatives and to ensure adherence to study protocols and regulatory requirements.
• Lead site level staff training with a focus on integrating RBQM and QbD into everyday operations, ensure training programs are updated to reflect the latest in clinical trial technologies and methodologies.
• Implement root cause analysis and corrective action/preventive action (CAPA) plans, with a focus on continuous improvement and innovation.
• Lead the development, revision, and implementation of Standard Operating Procedures (SOPs) related to site quality management, ensuring SOPs are aligned with the latest regulatory requirements, industry best practices, and modern quality management techniques.
• Maintain open communication with site staff, serving as a resource for quality related site issues.
• Collaborate with the broader Quality Management function to prepare for external audits and inspections, and support a comprehensive, integrated quality management program.
• Work closely with leadership to close identified gaps, driving continuous improvement initiatives that incorporate the latest quality management methodologies.
• Collaborate with Site Operations and other relevant functional groups to convert newly identified Walgreens locations into fully operational and compliant clinical trial sites.

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".

External Basic Qualifications

• Bachelor's degree and at least 4 years of experience in Clinical Trial Operations and Quality management OR High School/GED and at least 7 years of experience in Clinical Trial Operations and Quality management.
• Demonstrated deep understanding of the drug/device development process, including experience with new clinical trial models such as decentralized/hybrid trials.
• Comprehensive knowledge of ICH GCP, US CFR, and HIPAA regulations.
• Proven experience in implementing risk based quality management (RBQM), quality by design (QbD), and centralized monitoring techniques in clinical trials.
• Experience in the development, revision, and implementation of Standard Operating Procedures (SOPs) related to site quality management.
• Experience in developing, tracking, and reporting site level quality metrics.
• Proficient in root cause analysis and implementing corrective action/preventive action (CAPA) plans to drive continuous improvement.
• Strong ability to prioritize tasks, manage resources effectively, and meet deadlines in a dynamic environment.
• Excellent communication and interpersonal skills with the ability to collaborate across different functions.
• 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 30% of the time for business purposes (within state and out of state).

Preferred Qualifications

• Startup experience
• Decentralized/hybrid clinical trials experience

We will consider employment of qualified applicants with arrest and conviction records.