Senior Site Quality & Training Manager, RWE Clinical Trials
Address: 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-00001-Y
ID de la oferta 1502790BR
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.
About Walgreens
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
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".
#LI-TO1
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
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
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".
#LI-TO1
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
Salary Range$127500 - $204000 / Salaried
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