Manager Clinical Site Operations RWE Clinical Trials New Jersey/Remote

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

Job ID 1397364BR

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Job Summary

The Manager, Clinical Site Operations reports to the Director, Clinical Site Operations, and functions as the direct manager for patient-facing site staff supporting assigned studies. This role supervises clinical trial activities, the implementation of and adherence to study protocols, and oversees the schedules of assigned site staff to ensure best utilization of all resources and overall capacity planning. Additionally, the Manager is responsible for ensuring quality and adherence to standard operating procedures as well as federal and local regulations for all assigned studies.

Job Responsibilities

Supervise a subset of clinical research coordinators, both on-site and remote-based staff, as well as any other supporting staff of the clinical site that are working directly with patients.
Drive accountability for patient enrollment, ensuring Clinical Research Coordinators own the enrollment plan to meet recruitment goals for their specific studies.
Manage assigned staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations.
Oversee the schedules of assigned site staff to ensure best utilization of all resources and overall capacity planning.
Work with Director of Site Operations to evaluate and implement new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the sites.
Support deployment and use of all clinical trial technology utilized by the sites (e.g., eSource, eReg, eConsent)
Ensures the highest standard of integrity, quality, and operational excellence in clinical research activities and adherence to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, and other applicable federal, state, and local regulations for all assigned studies.
Participate in the conduct of initial and ongoing risk assessments and develop plans for approaching identified risks.
Collaborate with the site project management and quality functions to convert newly identified Walgreens’ locations into fully operational and compliant clinical trial sites.
Work closely with the clinical site quality function to ensure the Walgreens’ clinical trial sites are audit-ready at all times.
Coordinate with the clinical site project management function to facilitate monitoring visits, audits, and other interactions between site staff and sponsors for assigned studies.
Contribute to the development and ongoing revision of clinical site processes, procedures, templates, and other relevant organizational tools.

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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. WBAs 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 nations 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".

Basic Qualifications

Deep understanding of the drug/device development process including new clinical trials models
Exceptional working knowledge of ICH-GCP, US CFR, and HIPAA regulations
Experience working independently and making appropriate strategic decisions to operationalize and move clinical trials forward.
Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail
Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.
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 25% of the time for business purposes (within state and out of state).

Preferred Qualifications

Startup experience
Decentralized/hybrid clinical trials experience
Deep expertise of modern clinical trial site technologies (e.g., eReg, eSource, eConsent)
Tech-savvy with the experience applying new systems to everyday tasks
Experience conducting clinical trials in a retail pharmacy setting
Preferred candidate will be located in New Jersey, however, open to other locations.

Salary Range$122600 - $196200 / Salaried

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