Fernet Claire Email & Phone Number | SKILLS • Study coordination : until 10 at the same time (start up phase or/and follow up phase) :  Feasibility activities  Finance activities :Institution and/or Sponsor contract initiation and FUP, Per Subject Cost negotiation  Regulatory activities : Ethic Committees file preparation, HA and EC approbation tracking including Informed consent review for local submissions  Essential documents validation  Suppliers management and follow-up including quotation negotiation (Binders and CRF printing)  TC Minutes • Study budget management : Forecast and follow up (global budget until 1000 K€); invoices, investigator fees and additional fees validation • Study Drug : Study drug quantities estimation, labels, orders, stock follow up. Drug accountability reconciliation. • CRAs and Investigators communication : any kind (regulatory, Queries, amendments, IVRS activation,) • International database updates : data used for NDA reports, Essential documents tracking • CRAs and Investigators’ material supply : Start up phase and FUP iInvestigator material preparation and supply • Creation, preparation of study documents : Subject’s documents (visits schedule table, Subject’s patient cards and diaries, Study prescription) • Study document Tracking : xls trackers creation and follow up. Feasibility results, Start-up documents, Monitoring visit reports, CRA site visits, budget, Team contact lists, Key Study milestones, HA & EC document requirements and activities. • Study Specific Instruction Manual • Internal Study update reporting : Slides and presentation of key milestones • Key Opinion Leader event organization and follow up : Investigators’ meeting, Site initiated meeting, CRA’s meeting • TMF : Electronic and paper Filling according to SOPs. • Posters preparation – Publication follow up

Fernet Claire

SKILLS • Study coordination : until 10 at the same time (start up phase or/and follow up phase) :...
Paris, Paris, France

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Fernet Claire’s Email fernet.claire@ppdi.com

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Fernet Claire’s Location Paris, Paris, France

Fernet Claire’s Current Industry Ppd Trio Cirg

Fernet Claire’s Prior Industry Quintiles | Glaxosmithkline

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Work Experience

Ppd

Principal Contract Specialist

2015-07-01 00:00:00 - Present

Trio Cirg

Senior Clinical Trial Assistant and Clinical Start-up Specialist

2010-12-01 00:00:00 - Present

Quintiles

Senior Clinical Trial Assistant

2010-07-01 00:00:00 - 2010-11-01 00:00:00

Glaxosmithkline

Gestionnaire Essais Cliniques

1999-11-01 00:00:00 - 2010-06-01 00:00:00

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FAQ About Fernet Claire

Fernet Claire is located at
Paris, Paris, France

Fernet Claire is a SKILLS • Study coordination : until 10 at the same time (start up phase or/and follow up phase) :  Feasibility activities  Finance activities :Institution and/or Sponsor contract initiation and FUP, Per Subject Cost negotiation  Regulatory activities : Ethic Committees file preparation, HA and EC approbation tracking including Informed consent review for local submissions  Essential documents validation  Suppliers management and follow-up including quotation negotiation (Binders and CRF printing)  TC Minutes • Study budget management : Forecast and follow up (global budget until 1000 K€); invoices, investigator fees and additional fees validation • Study Drug : Study drug quantities estimation, labels, orders, stock follow up. Drug accountability reconciliation. • CRAs and Investigators communication : any kind (regulatory, Queries, amendments, IVRS activation,) • International database updates : data used for NDA reports, Essential documents tracking • CRAs and Investigators’ material supply : Start up phase and FUP iInvestigator material preparation and supply • Creation, preparation of study documents : Subject’s documents (visits schedule table, Subject’s patient cards and diaries, Study prescription) • Study document Tracking : xls trackers creation and follow up. Feasibility results, Start-up documents, Monitoring visit reports, CRA site visits, budget, Team contact lists, Key Study milestones, HA & EC document requirements and activities. • Study Specific Instruction Manual • Internal Study update reporting : Slides and presentation of key milestones • Key Opinion Leader event organization and follow up : Investigators’ meeting, Site initiated meeting, CRA’s meeting • TMF : Electronic and paper Filling according to SOPs. • Posters preparation – Publication follow up – News letters creation