Sharon Gagne Email & Phone Number | Responsible for creation, maintenance, quality review, and archival of TMF, to include Sponsor files. Assists the project team with accurately updating and maintaining clinical tracking systems Is responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s. Prepares and requests the necessary local authorities approvals Oversees and manages the agreements with hospitals and investigation centers Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project) Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow Collaborates with the project team in organizing Investigator’s and Monitor’s Meetings Collaborates in managing the follow-ups of the monitor’s activities Manages the telephone monitoring of projects Oversees and manages the payments of sites Keeps herself professionally abreast of all regulatory and operative aspects relevant to the clinical projects she will be assigned. Should be knowledgeable, following appropriate training's, in the application process for clinical studies, in force in the country(es) of work. Accordingly she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant.Acting Clinical Trials Office Administrative Assistant. Managing and oversight of the Trial Master File, from initial set-up through final archival. Monitored compliance of the TMF and supporting preparation of documentation required for regulatory agency inspections and internal audits. Oversaw set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. Periodic monitoring by quality assessments of clinical TMF documents where required, ensuring effective lifecycle management of the TMF. Supported assigned TMF corrective action plans under direction of Vice President of Clinical Operations. Enhanced efficiencies in document management practices.• Perform document management and administrative tasks that support Clinical device planning, communication, distribution, tracking, reconciliation and record management. • Run reports from the Clinical Device Management System (DMS) and other systems as needed • Create and maintain status tracking information for various device-related activities, such as site readiness, training completions, pending returns, outstanding data remediation tasks, etc. • Ensure clinical supply chain records and related documentation are complete and archived in both electronic format on SharePoint and in paper format in file room, including creation and maintenance of applicable folders to maintain record organization and tracking of any outstanding items for resolution. • Assist as directed with system account management and related record keeping, (e.g. SharePoint access, DMS access, training records) • Escalate issues and potential risk to trial and CSC management when warranted.• Ensure the maintenance, accuracy and completeness of physical paper and electronic central clinical files including study set up, scanning and filing. • Named archivist for Clinical Trial related activities per UK MHRA, or local US Site requirements where applicable, to retrieve documentation from archives. • Oversee audit preparation of documents when necessary • Provide relevant training to Clinical Operations Staff. • Organize, prepare and maintain offsite archives. • Assist with developing records management policies and best practices in compliance with corporate, legal, and regulatory requirements. • Represent R&D Records Management and Archiving in inter-organizational meetings and functional teams. • Interact with cross functional areas and external personnel, including supply, software vendors and records retention management (Iron Mountain). • Initiate R&D Documentation and Archiving and participate in implementing action plans for improvements within R&D. • Organize department and inter-department meetings and training. • Train and Supervise new employees. • Interact collaboratively in a team environment. • Maintain quality through Good Documentation Processes.• Create and maintain sponsor research binders containing clinical research protocols, consent forms, agreements, ongoing correspondence, financial information, and device tracking information in accordance with Regulatory guidelines. • Receive, track, and manage clinical trial data from study sites, as well as perform data entry and discrepancy management for clinical trials. Perform ad hoc trial-related tasks as requested by the database manager and clinical trial project leaders. • Oversight of process payment to vendors, including Investigators and consultants, by maintaining database, tracking expiration dates, generating purchase orders, processing invoices and following up on issued checks and bank drafts. Maintains Clinical portion of Health Care Compliance database. • Ensure compliance with company record retention policy through organization & maintenance of remote & on site clinical trial documentation. • Coordination of electronic Investigational and training meetings for Global Clinical Research Department. • Assist Sr. Administrative Assistant in the development, tracking, and maintenance of training records for all members of the Clinical department. Demonstrate the ability to effectively communicate, verbally and in writing, with internal and external customers at multiple levels. • Assist in efforts to prepare for Clinical trial monitoring visits. • Perform administrative tasks and provide ad hoc support to the Worldwide Director and other Clinical research department members as needed.Also referred to as Cytyc. • Knowledge of the Quality System Regulation (FDA QSR 21 CFR Part 820) and ISO 9001 Quality System standard. • Determine whether complaints are categorized appropriately for Potential Adverse Event and MDR reporting. • Review customer and technical support call information to determine complaint investigation requirements and look for trends in complaints. • Assess complaints and assign complaint investigators. • Assist in Validation of the complaint handling software, Trackwise. • Participates in process improvements within the complaint handling process.Interfaced with Pharmacovigilance Department & obtained outstanding safety information from study sites. Perform Adverse Event/Serious Adverse Event Coding, using MedDRA. • Co-monitored at site visits: reviewed source documents, assessed accuracy of CRF entries for medical history, eligibility, study procedures, Adverse Events & concomitant medications. • Perform data entry of Case Report Forms into clinical study databases & perform Quality Assurance for Data Management. Determine Visual Analog Scores. Assist in performing yearly audits on Contract Research Organizations. • Prepare and collect study related documents, including Regulatory documentation & patient source documents. Created & maintained Trial Master Files. Prepared & requested Regulatory documents from sites, tracked patient visits & followed up with sites to collect outstanding Case Report Forms. Coordinate & track billing between study sites/institutions & Accounts Payable. • Screen patients to determine eligibility for study specific protocols. Evaluate & select Principal Investigators, clinical study sites, Contract Research Organizations & outside vendors. Research FDA Debarment Listing for restricted Investigator’s. Serve as secondary contact for Pivotal & Pilot clinical trials. • Assist in Case Report Form design & development, institute internal guidance documents & participate in drafting Standard Operating Procedures. • Maintained departmental training records & Regulatory agency contact logs. Distributed monthly reports on current clinical studies & developed quarterly newsletters regarding ongoing clinical studies. • Daily responsibilities included direct support to the Director & Vice President of Regulatory Affairs & Clinical Operations. Interviewed candidates & supervised contract/temporary employees. • Additional tasks include editing/proof reading documents & typing/data entry. Maintaining departmental calendar, schedule onsite & offsite meetings & coordinate travel arrangements.

Sharon Gagne

Responsible for creation, maintenance, quality review, and archival of TMF, to include Sponsor files...
Clinton, Clinton, United States

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Sharon Gagne’s Email sharon.gagne@manpower.com

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Sharon Gagne’s Location Clinton, Clinton, United States

Sharon Gagne’s Current Industry BERG Health

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Work Experience

BERG Health

In-House CRA/eTMF-TMF Specialist

2017-12-01 00:00:00 - Present

CROMSOURCE

CTA 2

2017-03-01 00:00:00 - 2017-05-01 00:00:00

Promedior, Inc.on behalf of BioBridges

Clinical Documentation Specialist

2016-09-01 00:00:00 - 2016-11-01 00:00:00

Manpower Contractor

Clinical Supply Chain Administrator

2016-01-01 00:00:00 - 2016-04-01 00:00:00

Mindlance Contractor

Clinical Research Coordinator

2011-03-01 00:00:00 - 2011-06-01 00:00:00

Contractor

REM Consultant

2011-01-01 00:00:00 - 2013-06-01 00:00:00

Hologic

Product Complaint Associate II

2008-04-01 00:00:00 - 2010-01-01 00:00:00

Stryker Biotech

CRA 1

2004-03-01 00:00:00 - 2008-02-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Sharon Gagne

Sharon Gagne is located at
Clinton, Clinton, United States

Sharon Gagne is a Responsible for creation, maintenance, quality review, and archival of TMF, to include Sponsor files. Assists the project team with accurately updating and maintaining clinical tracking systems Is responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s. Prepares and requests the necessary local authorities approvals Oversees and manages the agreements with hospitals and investigation centers Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project) Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow Collaborates with the project team in organizing Investigator’s and Monitor’s Meetings Collaborates in managing the follow-ups of the monitor’s activities Manages the telephone monitoring of projects Oversees and manages the payments of sites Keeps herself professionally abreast of all regulatory and operative aspects relevant to the clinical projects she will be assigned. Should be knowledgeable, following appropriate training's, in the application process for clinical studies, in force in the country(es) of work. Accordingly she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant.Acting Clinical Trials Office Administrative Assistant. Managing and oversight of the Trial Master File, from initial set-up through final archival. Monitored compliance of the TMF and supporting preparation of documentation required for regulatory agency inspections and internal audits. Oversaw set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. Periodic monitoring by quality assessments of clinical TMF documents where required, ensuring effective lifecycle management of the TMF. Supported assigned TMF corrective action plans under direction of Vice President of Clinical Operations. Enhanced efficiencies in document management practices.• Perform document management and administrative tasks that support Clinical device planning, communication, distribution, tracking, reconciliation and record management. • Run reports from the Clinical Device Management System (DMS) and other systems as needed • Create and maintain status tracking information for various device-related activities, such as site readiness, training completions, pending returns, outstanding data remediation tasks, etc. • Ensure clinical supply chain records and related documentation are complete and archived in both electronic format on SharePoint and in paper format in file room, including creation and maintenance of applicable folders to maintain record organization and tracking of any outstanding items for resolution. • Assist as directed with system account management and related record keeping, (e.g. SharePoint access, DMS access, training records) • Escalate issues and potential risk to trial and CSC management when warranted.• Ensure the maintenance, accuracy and completeness of physical paper and electronic central clinical files including study set up, scanning and filing. • Named archivist for Clinical Trial related activities per UK MHRA, or local US Site requirements where applicable, to retrieve documentation from archives. • Oversee audit preparation of documents when necessary • Provide relevant training to Clinical Operations Staff. • Organize, prepare and maintain offsite archives. • Assist with developing records management policies and best practices in compliance with corporate, legal, and regulatory requirements. • Represent R&D Records Management and Archiving in inter-organizational meetings and functional teams. • Interact with cross functional areas and external personnel, including supply, software vendors and records retention management (Iron Mountain). • Initiate R&D Documentation and Archiving and participate in implementing action plans for improvements within R&D. • Organize department and inter-department meetings and training. • Train and Supervise new employees. • Interact collaboratively in a team environment. • Maintain quality through Good Documentation Processes.• Create and maintain sponsor research binders containing clinical research protocols, consent forms, agreements, ongoing correspondence, financial information, and device tracking information in accordance with Regulatory guidelines. • Receive, track, and manage clinical trial data from study sites, as well as perform data entry and discrepancy management for clinical trials. Perform ad hoc trial-related tasks as requested by the database manager and clinical trial project leaders. • Oversight of process payment to vendors, including Investigators and consultants, by maintaining database, tracking expiration dates, generating purchase orders, processing invoices and following up on issued checks and bank drafts. Maintains Clinical portion of Health Care Compliance database. • Ensure compliance with company record retention policy through organization & maintenance of remote & on site clinical trial documentation. • Coordination of electronic Investigational and training meetings for Global Clinical Research Department. • Assist Sr. Administrative Assistant in the development, tracking, and maintenance of training records for all members of the Clinical department. Demonstrate the ability to effectively communicate, verbally and in writing, with internal and external customers at multiple levels. • Assist in efforts to prepare for Clinical trial monitoring visits. • Perform administrative tasks and provide ad hoc support to the Worldwide Director and other Clinical research department members as needed.Also referred to as Cytyc. • Knowledge of the Quality System Regulation (FDA QSR 21 CFR Part 820) and ISO 9001 Quality System standard. • Determine whether complaints are categorized appropriately for Potential Adverse Event and MDR reporting. • Review customer and technical support call information to determine complaint investigation requirements and look for trends in complaints. • Assess complaints and assign complaint investigators. • Assist in Validation of the complaint handling software, Trackwise. • Participates in process improvements within the complaint handling process.Interfaced with Pharmacovigilance Department & obtained outstanding safety information from study sites. Perform Adverse Event/Serious Adverse Event Coding, using MedDRA. • Co-monitored at site visits: reviewed source documents, assessed accuracy of CRF entries for medical history, eligibility, study procedures, Adverse Events & concomitant medications. • Perform data entry of Case Report Forms into clinical study databases & perform Quality Assurance for Data Management. Determine Visual Analog Scores. Assist in performing yearly audits on Contract Research Organizations. • Prepare and collect study related documents, including Regulatory documentation & patient source documents. Created & maintained Trial Master Files. Prepared & requested Regulatory documents from sites, tracked patient visits & followed up with sites to collect outstanding Case Report Forms. Coordinate & track billing between study sites/institutions & Accounts Payable. • Screen patients to determine eligibility for study specific protocols. Evaluate & select Principal Investigators, clinical study sites, Contract Research Organizations & outside vendors. Research FDA Debarment Listing for restricted Investigator’s. Serve as secondary contact for Pivotal & Pilot clinical trials. • Assist in Case Report Form design & development, institute internal guidance documents & participate in drafting Standard Operating Procedures. • Maintained departmental training records & Regulatory agency contact logs. Distributed monthly reports on current clinical studies & developed quarterly newsletters regarding ongoing clinical studies. • Daily responsibilities included direct support to the Director & Vice President of Regulatory Affairs & Clinical Operations. Interviewed candidates & supervised contract/temporary employees. • Additional tasks include editing/proof reading documents & typing/data entry. Maintaining departmental calendar, schedule onsite & offsite meetings & coordinate travel arrangements.

Sharon Gagne currently works in the BERG Health |

No Languages Available

Sharon Gagne has prior
experience in the following industries:
CROMSOURCE | Promedior, Inc.on behalf of BioBridges | Manpower Contractor | Mindlance Contractor | Contractor | Hologic | Stryker Biotech

Sharon Gagne has the following professional experience:
BERG Health | CROMSOURCE | Promedior, Inc.on behalf of BioBridges | Manpower Contractor | Mindlance Contractor | Contractor | Hologic | Stryker Biotech