Janelle Edwards work email
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Janelle Edwards personal email
Janelle Edwards is a Study Team Manager at Thermo Fisher Scientific. She possess expertise in cro, clinical trials, gcp, pharmaceutical industry, edc and 17 more skills.
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Startup ManagerThermo Fisher Scientific Dec 2021 - PresentWaltham, Ma, UsOn December 8, 2021, Thermo Fisher Scientific completed acquisition off PPD -
Study Team ManagerPpd Aug 2021 - PresentWilmington, Nc, Us -
Senior Site Start-Up & Regulatory SpecialistSyneos Health Apr 2021 - Aug 2021Morrisville, Nc, Us -
Site Start-Up & Regulatory Specialists IiSyneos Health Mar 2004 - Apr 2021Morrisville, Nc, Us
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Study Start-Up And Regulatory Specialist IiInc Research Oct 2012 - Sep 2016Raleigh, North Carolina, UsPerforms assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. At a project and local level, may act as Site Start-up Lead (SSUL). May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Manager (PM) or SSUL as appropriate , may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PM/SSUL at the project level and line manager for deliverables. At a project level , may act as SSUL for local studies. May act as the Country Start-Up Advisor (CSA). -
Regulatory Records SpecialistInc Research Jun 2006 - Oct 2012Raleigh, North Carolina, UsCoordinates the workflow process for paper and electronic document management. Prioritizes work for the Document Control Specialist team. Assists in resourcing to accommodate ongoing workflow. Guides and trains junior team members in functional areas of expertise. Leads quality assurance and process improvement efforts, as needed. Performs support tasks related to creating and maintaining the document/file repository and archival for all site-related paper documents, electronic documents, and other documents requiring document control.
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Document Maintenance AssistantInc Research Mar 2004 - Jun 2006Raleigh, North Carolina, UsResponsible for effectively and efficiently providing support for the collection, copying, cataloging, and filing of study-specific documents. Maintain all study documentation according to the ICH guidelines, Kendle and/or sponsor SOPs and Central File/Archive File operative rules.
Janelle Edwards Skills
Janelle Edwards Education Details
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Baker College Business And Corporate ServicesBusiness
Frequently Asked Questions about Janelle Edwards
What company does Janelle Edwards work for?
Janelle Edwards works for Thermo Fisher Scientific
What is Janelle Edwards's role at the current company?
Janelle Edwards's current role is Study Team Manager.
What is Janelle Edwards's email address?
Janelle Edwards's email address is ja****@****lth.com
What schools did Janelle Edwards attend?
Janelle Edwards attended Baker College Business And Corporate Services.
What skills is Janelle Edwards known for?
Janelle Edwards has skills like Cro, Clinical Trials, Gcp, Pharmaceutical Industry, Edc, Ich Gcp, Regulatory Affairs, Regulatory Submissions, Clinical Research, Clinical Development, Biotechnology, Ctms.
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