amanda klein
Sr Process Control Manager at Novartis Oncology
sr process control manager novartis
operation professional strong management skill . lead example upmost attention quality industry compliance . exceptional organizational capability unique ability evaluate process foresight developing implementing streamlined efficient mechanism . proactively committed meeting exceeding target cross functional collaboration innovation . > mba - anticipated completion 2017 > master science management focus organizational change management > bachelor art journalism & medium study minor psychology
Novartis Oncology
https://www.linkedin.com/company/novartis-oncology
Sr Process Control Manager
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Novartis
Senior Clinical Portfolio Specialist
• 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
Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
Senior Regulatory Document Specialist
• 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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Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
Regulatory Document Specialist - Oncology
• 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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Novartis Pharmaceuticals
https://www.linkedin.com/company/novartis
Administrative Assistant/Contract Admin/Lead Investigator Notification Coordinator - Oncology
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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Wyeth Consumer Healthcare
Administrative Assistant to VP of Medical Sales and Marketing
• Managed daily physician requests
• Coordinated department meetings and maintaining the team calendar
• Processed expense reports 
.
Madison, NJ
Rutgers University Foundation
Office Assistant
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
Green Belt Certified
Lean Six Sigma
MBA
Master of Business Administration (M.B.A.)
Centenary University
https://www.linkedin.com/school/centenary-university/
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Management, Organizational Change Management
Master of Science (MS)
College of Saint Elizabeth
https://www.linkedin.com/school/saint-elizabeth-university/
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Journalism and Media Studies
Bachelor of Arts (B.A.)
Rutgers University
https://www.linkedin.com/school/rutgersu/
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https://ch.linkedin.com/in/mieke-borgs-9438376
Mieke Borgs
Head Clinical Operations Europe at BeiGene
Basel
https://ch.linkedin.com/in/jambstew
Ben Stewart
Lifecycle Leader at Roche
Basel
https://ch.linkedin.com/in/geoffrey-williams-a6bbb73a
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
Basel Metropolitan Area
https://ch.linkedin.com/in/lisa-gifford-51925039
Lisa Gifford
Development Unit Operations, Ophthalmology
Basel
https://www.linkedin.com/in/diane-mohr-6169a4a
Diane Mohr
Pharmaceutical Consultant, Biomarker & Diagnostic Sample Logistics and Operations
Howell Township, NJ
https://www.linkedin.com/in/david-kornhauser-9a949116
David Kornhauser
Independent Consulting, Clinical Pharmacology and Drug Development at
Owings Mills, MD
https://www.linkedin.com/in/lisa-garrison-a2673488
Lisa Garrison
Data Management Lead at Bristol-Myers Squibb
Princeton, NJ
https://www.linkedin.com/in/loretta-prem-b566a353
Loretta Prem
eClinical Operations Analyst (BA) at Bristol-Myers Squibb
Princeton, NJ
https://www.linkedin.com/in/robert-hedden-m-s-mifiree-cfo-cfps-90470a25
Robert Hedden, M.S., MIFireE, CFO, CFPS
Fire Fighter - Retired
Greater Philadelphia
https://www.linkedin.com/in/dianerandall
Diane Randall
Associate Director at Bristol-Myers Squibb
Levittown, PA
https://www.linkedin.com/in/diane-godish-47a05b6
Diane Godish
External Protocol Data Manager at Bristol-Myers Squibb
Levittown, PA
https://www.linkedin.com/in/kenneth-galitski-1664a1120
Kenneth Galitski
Subject Matter Expert at Results Company
Norristown, PA
https://www.linkedin.com/in/jean-fortunato-5b702230
Jean Fortunato
Senior External Data Coordinator at Bristol-Myers Squibb Medical Imaging
Pennington, NJ
https://www.linkedin.com/in/john-hunter-051896168
John Hunter
Driver/mover at Centurion Movers
Greater Philadelphia
https://www.linkedin.com/in/lynne-hawkins-8b562539
Lynne Hawkins
Executive Associate II at Bristol-Myers Squibb
Trenton, NJ
https://www.linkedin.com/in/4davidhamilton
David Hamilton
Founder at Biopharmatics (BPX)
New York City Metropolitan Area
https://www.linkedin.com/in/joshcorr
Joshua Corriveau PharmD MBA
Senior Director, Global Field Medical Excellence at LEO Pharma
New York City Metropolitan Area
https://www.linkedin.com/in/aayush-tandon-0118008
Aayush Tandon
Director - US Forecasting and BD&L at Novartis
New York City Metropolitan Area
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…
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Liked by Amanda Klein
Amanda Miller
https://www.linkedin.com/in/amanda-miller-7241116
Miramax TV
Los Angeles, CA
Amanda Klein
https://www.linkedin.com/in/amanda-e-klein
Literacy Specialist at Vernon Hills High School
Libertyville, IL
Amanda Klein
https://br.linkedin.com/in/amandabklein
Head de Pessoas e Cultura na SharePrime
Porto Alegre, RS
Amanda Klein
https://www.linkedin.com/in/amanda-klein-a63a427
teacher at Saddle Brook High School
Wallington, NJ
Amanda Klein
https://pt.linkedin.com/in/a-c-k
Associate na People Mining
Lisbon Metropolitan Area
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Rutgers Alumni
https://www.linkedin.com/groups/37533