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Associate Director GCP Compliance
3 days ago
Idaho State Job Bank Boise, United StatesAssociate Director GCP Compliance at Takeda Pharmaceuticals in Boise, Idaho, United States Job Description By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be pr ...
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System Medical Director Research
17 hours ago
St. Luke's Health System Boise, United StatesOverview · At St. Luke's Health System, our Research Department is at the forefront of advancing medical knowledge and improving patient care. We are committed to conducting innovative research that translates into real-world solutions and transformative healthcare practices. Our ...
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Clinical Quality Operations Lead
3 weeks ago
Merck Boise, United StatesJob Description · **Join our team as a Clinical Quality Operations Lead - Inspection Strategy** and be at the forefront of developing and implementing policies, processes, and procedures related to Health Authority inspections. Your expertise and guidance will ensure the smooth m ...
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Clinical Quality Operations Manager
3 weeks ago
Idaho State Job Bank Boise, United StatesClinical Quality Operations Manager (Remote) at Merck in Boise, Idaho, United States Job Description Job Description It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clini ...
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Idaho State Job Bank Boise, United StatesSenior Country Clinical Quality Management Lead (Remote) at Merck in Boise, Idaho, United States Job Description Job Description It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulati ...
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Research System Medical Director
1 day ago
St. Luke's Health System - Boise, ID Boise, United StatesAt St. Luke's Health System, our Research Department is at the forefront of advancing medical knowledge and improving patient care. We are committed to conducting innovative research that translates into real-world solutions and transformative healthcare practices. Our dedicated ...
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Local Trial Manager
1 day ago
Idaho State Job Bank Boise, United StatesLocal Trial Manager - Oncology-Solid Tumor - Remote/US at ICON Strategic Solutions in Boise, Idaho, United States Job Description As a Local Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligen ...
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Senior Clinical Operations Manager
3 days ago
Idaho State Job Bank Boise, United StatesSenior Clinical Operations Manager at Takeda Pharmaceuticals in Boise, Idaho, United States Job Description By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be p ...
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Clinical Research Manager
6 days ago
Idaho State Job Bank Boise, United StatesClinical Research Manager - Infectious Disease/Vaccine (REMOTE) at Merck in Boise, Idaho, United States Job Description Job Description Position Description: Clinical Research Manager - Infectious Disease/Vaccine (REMOTE) This role is primarily accountable for the end-to-end perf ...
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Lead Cloud Software Engineer
3 days ago
Idaho State Job Bank Boise, United StatesLead Cloud Software Engineer at Highmark Health in Boise, Idaho, United States Job Description Company : Highmark Health Job Description : JOB SUMMARY This job is a leader of cloud-first application design to drive the organization's next-generation technologies. The incumbent wo ...
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Idaho State Job Bank Boise, United StatesSenior Clinical Research Monitor, Western Region at Edwards Lifesciences in Boise, Idaho, United States Job Description Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our inn ...
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Analytic Data Engineer
3 weeks ago
Idaho State Job Bank Boise, United StatesAnalytic Data Engineer at Highmark Health in Boise, Idaho, United States Job Description Company : Highmark Health Job Description : JOB SUMMARY This job architects and engineers solutions associated with analytic data for the organization and, working closely with the IT teams, ...
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Senior Clinical Trial Coordinator
3 days ago
Idaho State Job Bank Boise, United StatesSenior Clinical Trial Coordinator at J&J Family of Companies in Boise, Idaho, United States Job Description Senior Clinical Trial Coordinator W Description Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Senior Clinical Trial Coordinator II, located in Danvers, M ...
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Idaho State Job Bank Boise, United StatesDirector Quality Assurance Infectious Diseases/Vaccines at Merck in Boise, Idaho, United States Job Description Job Description Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compl ...
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System Medical Director Research
4 days ago
Idaho State Job Bank Boise, United StatesSystem Medical Director Research at St. Luke's Health System in Boise, Idaho, United States Job Description Overview At St. Luke's, our patients come from all walks of life and so do we We strive to foster an environment that embraces our employees' unique strengths, experiences, ...
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Clinical Quality Specialist
3 days ago
Idaho State Job Bank Boise, United StatesClinical Quality Specialist at Bausch Health in Boise, Idaho, United States Job Description Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Gene ...
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IT Enterprise Cloud Architect
1 week ago
Micron Technology Boise, United StatesOur vision is to transform how the world uses information to enrich life for all. · Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and ...
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Manager, Cybersecurity Engineering
2 weeks ago
Idaho State Job Bank Boise, United StatesManager, Cybersecurity Engineering at Cornerstone onDemand in Boise, Idaho, United States Job Description The Manager, Cybersecurity Engineering position is a hands-on role that involves evaluating and enforcing security and compliance controls. This position plays an integral ro ...
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Sr. Enterprise Cloud Architect
1 week ago
Idaho State Job Bank Boise, United StatesSr. Enterprise Cloud Architect (Hybrid/Remote) at UMB Bank in Boise, Idaho, United States Job Description The Enterprise Architecture team is comprised of Enterprise and Solution architects playing a critical role in providing enterprise-level project solutions and strategies. We ...
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Senior Director
1 week ago
Idaho State Job Bank Boise, United StatesSenior Director - Information Security Governance, Risk & Compliance (GRC) - Remote at Ryder System in Boise, Idaho, United States Job Description Job Seekers can review the Job Applicant Privacy Policy by clicking HERE. (Summary The Senior Director IS Gov Risk & Compliance is a ...
Senior Manager GCP Compliance - Boise, United States - Idaho State Job Bank
Description
Senior Manager GCP Compliance at Takeda Pharmaceuticals in Boise, Idaho, United States Job Description By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .
I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description OBJECTIVES/PURPOSE + Lead compliance management efforts related to quality events and auditsfor clinical trial deliveryfunctions to ensure engagement of appropriate stakeholders, conduct of robust investigations and root cause analysis,appropriate CAPA plan development, and on time completion of CAPA/EC actions + Manage and coordinatecompliance assessments for clinical trial delivery functions including liaising with R&D QA and functional representatives, development of assessment plan, and timely completion and reporting + Track and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery ACCOUNTABILITIES Compliance Management + Manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting + Support study teams and functional areas during internal audits by providing guidance on audit scope, facilitating audit requests, and managing the audit response process + Serve as the GCP Compliance liaison for clinical trial functional areas and study teams and support study execution teams with compliance to clinical trial delivery procedures and assist with developing and implementing mitigation and escalation strategies Compliance Assessments + Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance + Liaise with process owners and functional areas to develop and implement effective mitigation and escalation strategies for projects to address risks and issues + Develop and leadcompliance assessments to address GCP Quality Plan CAPAs/ECs and liaise with QA to ensure adherence to the plan GCP Compliance Metrics and Reporting + Partner with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities + Identifyand track KPIs, metrics and dashboards to track process quality and compliance Other + Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers + Act as role model for Takeda's values EDUCATION,BEHAVIOURAL COMPETENCIES AND SKILLS :
+ Bachelor's degree preferred or commensurate with experience + 6 + years' experience in the pharmaceutical in dustry and/or clinical research organization + Solid knowledge of clinical trial management and/or GCP compliance processes + Experience in problem solving, negotiations and collaborative team building with non-direct r e p orts and other stakeholders is required + Comprehensive knowledge of regulatory requirements governing clinical trials and industry best practices + Strong planning, execution, and communication skills + Advanced knowledge of drug development and clinical trial processes, including related standards and documents. + Good knowledge of clinical development training and process management, methods, and tools + Must be able to efficiently utilize computer software programs such as Microsoft Office for general use , project management and presentations ADDITIONAL INFORMATION + This position is currently classified as 'remote' in accordance with Takeda's Hybrid and Remote Work policy.