(Job Number: 013337) US-PA-Conshohocken Description
At Walgreens, we help people get, stay and live well. That’s our core purpose and the difference we make in people’s lives every day. Our purpose has shaped the direction of our company since Charles R. Walgreen Sr. founded his first drugstore in 1901, and it still does today.
Our team members make that purpose come to life in our more than 8,000 stores in all 50 states, the District of Columbia and Puerto Rico, in our call centers, distribution centers, clinics, specialty pharmacies, infusion and respiratory service locations and corporate offices. In fact, those daily demonstrations of our purpose have helped Walgreens become an industry leader and a household name.
Walgreens has something for everyone who wants to build a successful career. Here, you’ll find supportive co-workers, an innovative environment and the tools you need to expand your skills, help build healthy communities and advance your career.
QC & Analysis Clinical Trials Manager is responsible to ensure the overall consistency and quality of execution of clinical trials in the HealthCare Clinics at Select Walgreens. Develop and implement the quality control program, analyze the results and work with the clinical trials leadership team to develop and implement programs that ensure continuous monitoring of the clinical trial protocol(s) and federal regulations adherence. This role is integral in preparing the clinical trial site for any trial related internal or external audits, inspections or onsite reviews. Continuously assess opportunities for improvements as it relates to the overall quality and conduct of clinical trials. Responsible for the quality oversight of multiple investigative sites across multiple clinical trial studies, ensuring the integrity and validity of the study data is maintained.
Establish and maintain effective strategies, systems and procedures, ensuring adherence with applicable global GCP standards as they relate to the conduct of clinical trials.
Develop and manage audit schedule and ensure the readiness of inspection at clinical sites.
Partner with key internal groups to develop and meet quality objectives.
Develop and track key quality performance metrics to identify trends and mitigate emerging quality issues.
Host regulatory inspections.
Support in preparing responses to observations from inspections and audits.
Ensure, where appropriate, interface/communication with authorities for any GCP related activity (for example: local Health Authority [HA] inspections).
Ensure all protocol deviation’s/violations are properly managed and reported to appropriate authorities.
Responsible for multiple projects and must possess full knowledge and understanding of all assigned clinical protocols.
Must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.
Completes quality improvement reviews within the department.
Flexibility in work schedule when possible must be maintained to ensure coverage of study responsibilities.
Assists physicians and protocol coordinator as needed, to document and submit patient adverse events to the IRB, Research Sponsor/PI and FDA.
Coordinates audits/monitoring visits/initiation visits for pharmaceutical and cooperative group trials.
Excellent communication and interpersonal skills required to communicate with patients, families, physicians, providers and nurses.
Maintain integrity and quality of research data, patient enrollment process, data analysis for various medical publications and reports, protocol implementing, research data base management, and IRB submission.
Travel to clinical trial sites, research sponsors, participate in advisory board meetings for the industry and will have direct contact with the pharmaceutical industry.
Ensures the integrity and validity of the study data are maintained.
Responsible for interfacing with investigative sites to monitor the conduct and assess the progress of clinical research studies to ensure compliance with protocol(s) and applicable Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines, and any additional applicable regulations as required.
Performs onsite Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified and the site’s activities are in compliance with the clinical trial protocol and all applicable governmental and regulatory/ethics regulations.
Follows patients’ progress throughout clinical trial participation, ensuring compliance with protocol adherence. Track patients enrolled in clinical trials for Serious Adverse Events, ensuring that all SAEs are reported to the appropriate regulatory bodies.
Reviews regulatory documentation/file at the site for completeness, collects updated forms as applicable.
Attends team/sponsor teleconferences and/or training meetings as required.
Basic Qualifications & Interests
Bachelor’s Degree and at least 7 years of experience in clinical research and quality management: OR a Master’s Degree and at least 5 years of experience in clinical research and quality management.
At least 5 years of clinical research experience in the pharmaceutical industry.
At least 5 years of experience complying with GCP, ICH and FDA regulatory requirements.
At least 5 years of experience authoring and managing the CAPA and Root Cause Analysis process.
At least 5 years of experience effectively facilitating and planning for site audits.
At least 5 years of experience utilizing various Microsoft Office programs and tools.
Excellent communication skills and ability to interact competently and professionally (both verbal and written) at all levels within a complex clinical research environment.
Strong problem solving and decision making skills, flexibility and adaptability.
Knowledge of and ability to perform the following monitoring tasks: regulatory document review, source data verification, (e)CRF review, drug accountability and study supply inventory, and documenting the above activities including any identified issues and action items for resolution.
Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
Ability to maintain professional composure when found in stressful work situations.
At least 5 years of experience in indirect management of team members, including assisting in the development, training and assignment of work/projects to other team members.
Willing to travel at least 40% of the time for business purposes (within state and out of state).
Preferred Qualifications & Interests
Master’s Degree / MBA.
National Institute of Health Human Subjects Protection Certification; CCRP or CCRC certification preferred.
Walgreens - 9 months ago
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At Walgreens, we help people get, stay and live well. That is our core purpose and the difference we make in people's lives every day. Our...