Amanda Klein
Sr Process Control Manager at Novartis Oncology
Sr Process Control Manager at Novartis
Operations professional with strong management skills. Leads by example with the upmost attention to quality and industry compliance. Exceptional organizational capabilities with the unique ability to evaluate processes with the foresight of developing and implementing more streamlined and efficient mechanisms.  Proactively committed to meeting and exceeding targets through cross functional collaboration and innovation.   

> MBA - Anticipated completion 2017
> Master of Science in Management with a focus on Organizational Change Management 
> Bachelor of Arts in Journalism & Media Studies with a minor in Psychology
Novartis Oncology
https://www.linkedin.com/company/novartis-oncology
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Sr Process Control Manager
Novartis
• Develop detailed reports using study management systems for regulatory tracking, metrics, and document distributions 
• Actively update trial information and milestones in the Clinical Trial Management System 
• Core team member in accelerated study start-up pilot and involved in cross-functional knowledge share activities
• Identify efficiencies by utilizing gap analysis and develop process plan
• Manage diverse portfolio including TCO, CLT, and OCD clinical trials and oversight of pivotal trial maintenance document collection
• Cross train to expand expertise and align with the business strategy
• Oversee study start up and post start up activities for accuracy, compliance, and audit readiness
East Hanover
Senior Clinical Portfolio Specialist
Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
• Participate in monthly Monitoring Optimization and Innovation (MOI) leadership meetings as the Regulatory Document Management (RDM) expert 
• Developed and maintain the Regulatory Document Management OneNote notebook, a centralized multi-user collaboration program which houses templates, forms, meeting minutes, and onboarding information
• Manage and delegate clinical trial assignments to team members and ensure a balanced workload 
• Coordinate quarterly Medical Terminology trainings to enhance the teams understanding of cancer and its effect on the human body   
• Host monthly RDM team meetings and oversee action items to align cross divisional teams
• Maintain the highest professional standards as demonstrated on high pressure pivotal and key studies
• Achieve document quality and maintenance of Novartis Trial Master File (TMF) submissions for protocols, amended protocols, and revised informed consents.  
• Collaborate with Investigators and Regulatory Coordinators to ensure milestones are met
• Oversee operational management of the RDM team and liaise with internal teams and external vendors to support the business strategy 
• Generate detailed reports using study management systems for regulatory tracking, metrics, and document distributions 
• Mentor and train new associates throughout the onboarding process to strengthen our process and identify any gaps
• Create working practice and training documents with high level of quality and compliance
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Senior Regulatory Document Specialist
Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
• Central regulatory contact for Oncology/Hematology and Oncology Translational Medicine (OTM) trials. Ranging from 60 to 70 active sites.
• Ensure document quality and maintenance of Novartis Trial Master File (TMF) submissions for protocols, amended protocols, and revised informed consents.  
• Collaborate with Principle Investigators and Regulatory Coordinators in Study Start Up trials to ensure First Patient First Visit targets are met. 
• Primary liaison with Project Managers, Contract Managers, and Novartis Trial Leaders. Key role in weekly meetings; providing metrics and reports of site progress.
• Generate detailed site reports in ClinAdmin for regulatory document distribution for follow up notifications and tracking. 
• Provide regulatory details in the Novartis knowledge management system to organize and prioritize key sites.  
• Collect FDA regulated documents and forms and complete TMF submissions with accuracy and completeness. Confirm document release for internal and external audits and inspection readiness.
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Regulatory Document Specialist - Oncology
Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
Continually noted for strong work ethic and offered opportunities to work in various departments throughout the organization.  Worked with a team of 10 professionals, partner with physicians and other  constituencies to assure that research programs meet all requirements and federal standards. Commended by supervisors for:
• Excellent time management, meeting all deadlines.
• Ability to review processes and make recommendations for change which result in cost savings.
• Cross functional collaboration to produce innovative and creative solutions
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Administrative Assistant/Contract Admin/Lead Investigator Notification Coordinator - Oncology
Wyeth Consumer Healthcare
• Managed daily physician requests
• Coordinated department meetings and maintaining the team calendar
• Processed expense reports 
.
Madison, NJ
Administrative Assistant to VP of Medical Sales and Marketing
Rutgers University Foundation
Responsible for organizing weekly interviews. Collected essential employment paperwork and coordinated weekly training sessions and materials. Prepared daily worksheets of employee progress and attendance reports.
New Brunswick, NJ
Office Assistant
Green Belt Certified
Lean Six Sigma
Master of Business Administration (M.B.A.)
MBA
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Centenary University
https://www.linkedin.com/school/centenary-university/
Master of Science (MS)
Management, Organizational Change Management
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College of Saint Elizabeth
https://www.linkedin.com/school/saint-elizabeth-university/
Bachelor of Arts (B.A.)
Journalism and Media Studies
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Rutgers University
https://www.linkedin.com/school/rutgersu/
https://ch.linkedin.com/in/mieke-borgs-9438376
Basel
Mieke Borgs
Head Clinical Operations Europe at BeiGene
https://ch.linkedin.com/in/jambstew
Basel
Ben Stewart
Lifecycle Leader at Roche
https://ch.linkedin.com/in/geoffrey-williams-a6bbb73a
Basel Metropolitan Area
Geoffrey Williams
Leading a self-directed team of exceptional data scientists, advancing industry-leading, end-to-end risk prediction platform & business intelligence solutions, through a humanistic, empowering, visionary leadership style
https://ch.linkedin.com/in/lisa-gifford-51925039
Basel
Lisa Gifford
Development Unit Operations, Ophthalmology
https://www.linkedin.com/in/diane-mohr-6169a4a
Howell Township, NJ
Diane Mohr
Pharmaceutical Consultant, Biomarker & Diagnostic Sample Logistics and Operations
https://www.linkedin.com/in/david-kornhauser-9a949116
Owings Mills, MD
David Kornhauser
Independent Consulting, Clinical Pharmacology and Drug Development at
https://www.linkedin.com/in/lisa-garrison-a2673488
Princeton, NJ
Lisa Garrison
Data Management Lead at Bristol-Myers Squibb
https://www.linkedin.com/in/loretta-prem-b566a353
Princeton, NJ
Loretta Prem
eClinical Operations Analyst (BA) at Bristol-Myers Squibb
https://www.linkedin.com/in/robert-hedden-m-s-mifiree-cfo-cfps-90470a25
Greater Philadelphia
Robert Hedden, M.S., MIFireE, CFO, CFPS
Fire Fighter - Retired
https://www.linkedin.com/in/dianerandall
Levittown, PA
Diane Randall
Associate Director at Bristol-Myers Squibb
https://www.linkedin.com/in/diane-godish-47a05b6
Levittown, PA
Diane Godish
External Protocol Data Manager at Bristol-Myers Squibb
https://www.linkedin.com/in/kenneth-galitski-1664a1120
Norristown, PA
Kenneth Galitski
Subject Matter Expert at Results Company
https://www.linkedin.com/in/jean-fortunato-5b702230
Pennington, NJ
Jean Fortunato
Senior External Data Coordinator at Bristol-Myers Squibb Medical Imaging
https://www.linkedin.com/in/john-hunter-051896168
Greater Philadelphia
John Hunter
Driver/mover at Centurion Movers
https://www.linkedin.com/in/lynne-hawkins-8b562539
Trenton, NJ
Lynne Hawkins
Executive Associate II at Bristol-Myers Squibb
https://www.linkedin.com/in/4davidhamilton
New York City Metropolitan Area
David Hamilton
Founder at Biopharmatics (BPX)
https://www.linkedin.com/in/joshcorr
New York City Metropolitan Area
Joshua Corriveau PharmD MBA
Senior Director, Global Field Medical Excellence at LEO Pharma
https://www.linkedin.com/in/aayush-tandon-0118008
New York City Metropolitan Area
Aayush Tandon
Director - US Forecasting and BD&L at Novartis
Liked by Amanda Klein
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As a father, I can think of few things more important than ensuring families have the time and flexibility to welcome their children to the world and…
https://www.linkedin.com/in/amanda-miller-7241116
Los Angeles, CA
Amanda Miller
Miramax TV
https://www.linkedin.com/in/amanda-e-klein
Libertyville, IL
Amanda Klein
Literacy Specialist at Vernon Hills High School
https://br.linkedin.com/in/amandabklein
Porto Alegre, RS
Amanda Klein
Head de Pessoas e Cultura na SharePrime
https://www.linkedin.com/in/amanda-klein-a63a427
Wallington, NJ
Amanda Klein
teacher at Saddle Brook High School
https://pt.linkedin.com/in/a-c-k
Lisbon Metropolitan Area
Amanda Klein
Associate na People Mining
Rutgers Alumni
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