Records Management/Documentation Specialist

Sharon M. Gagne

** ******* ****

Sterling, MA ***64

*******@*******.***

Objective

·Seeking a permanent, full-time (Remote) position, as an eTMF/TMF Specialist/Clinical Trial Associate. Industries include the Pharmaceutical, Medical Device, and Biotechnology Industry.

Experience

Records Associate II/TMF QC Reviewer/TMF Specialist

Just in Time GCP Warrington, PA May 2021 – March 2025

·Participates in TMF Record Processing.

·Performs record quality checks based on client business documents and records standards.

·Performs review of record metadata to ensure it aligns with client business rules.

·Performs secondary quality checks of records and apply self-evident corrections as per client business rules.

·Ensures that documents reviewed have been categorized correctly and metadata has been assigned based on client review expectations and business rules.

·Logs queries for issues found during quality check.

·Uploads and classifies documents to the eTMF.

·Performs record quality checks prior to document upload based on client business documents and records standards.

·Assigns metadata based on client business standards.

·Communicates trends and issues to the Supervisor.

·Participates in reconciliation and/or remediation work.

·Ensure all work activities are performed in compliance with requirements of Good Clinical Practice.

·Conduct quality review of Trial Master File (TMF) in preparation for regulatory inspection.

·Assist in TMF record QC for full and risk-based review.

·Ensure that documents reviewed have been filed correctly and metadata has been assigned based on client conventions.

·Manage the start of the QC review for assigned studies based on the QC schedule.

·Generate queries for quality findings identified during the TMF review.

·Assist with communicating missing documents to study team and follow-up as needed.

·Help to resolve queries for assigned studies.

·Communicate trends in issues to TMF Manager.

·Upload documents to eTMF as needed.

·Assist with preparing documents ensuring that study documents are inspection ready.

Clinical Research Associate – TMF/eTMF Specialist

Berg Health, LLC Dec 2017 – Mar 2021

·Oversees clinical monitoring activities outsourced to CRO or contract CRAs; Co-monitors or perform sponsor visits to the study sites with the assigned CRAs as required; Reviews, comments & documents monitoring visit report reviews and escalates issues to clinical operations project lead as appropriate.

·Creates & maintains study specific tracking tools and project files as needed.

·Assists in the preparation of site and in-house Sponsor inspections.

·Assists with the final preparation of the Clinical Study Report and other clinical documents.

·Manages clinical documents and ensures documents are always current and ‘inspection ready.

·Effectively communicates with study team members and works closely to address challenges.

·Representing Clinical Operations at study team meetings and participate in

·collaborative efforts.

·Participates in the set-up of the clinical database (UAT testing).

·Helps to identify, create, and establish study tools for department.

·Consistently performs duties within established Standard Operating Procedures and in accordance with Good Clinical Practices.

·Ability to review and perform Investigational Medicinal Product accountability, if required.

·Performs verification and quality control of essential regulatory documents and is well versed in the organization of a Trial Master File (TMF)/electronic Trial Master File (eTMF).

·Manages the eTMF systems and ensures TMF Inspection Readiness is always current and ‘inspection ready’.

·Responsible for scanning, organizing, and uploading documents to the eTMF.

·Data integration from Wingspan to SureClinical.

·Responsible for ensuring the TMF is complete, contemporaneous, and quality ensured.

·Manages TMF projects and performs a risk-based review of TMF activities being performed by Clinical Operations and external vendors.

·Ensures key performance indicators (KPIs) are met.

·Manage TMF projects, assist with overall change management, and build collaborative relationships with cross-functional teams.

·Provide support to Clinical Operations during eTMF implementation, audits, and/or regulatory inspections.

·Ensure functional compliance with TMF/eTMF SOP's, relevant TMF/eTMF process-supporting guidance’s and applicable global regulations.

·Perform risk-based quality content reviews and monitor internal/external KPIs.

·Represent TMF/eTMF Operations at study team meetings, participate in collaborative efforts and play an important cross-functional role in TMF/eTMF document retrieval and management.

·Ensure documents which fail TMF/eTMF quality content and/or TMF/eTMF inspection readiness review are effectively remediated by internal/external representatives.

·Monitor and identify study specific TMF/eTMF trends and escalate concerns to Head of Clinical Operations.

·Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.

Clinical Trial Administrator II

CROMSOURCE Mar 2017 – May 2017

·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.

·Preparation, handling, distribution, collection, filing, and archiving clinical documentation and reports.

·Prepares and requests the necessary local authority approvals.

·Oversees and manages the agreements with hospitals and investigational centers.

·Collaborate 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.

·Collaborate with the project team in organizing Investigator’s and Monitor’s Meetings.

·Collaborates in managing the follow-ups on the monitor’s activities.

·Manages the telephone monitoring of projects.

·Oversees and manages the payments of sites.

·Knowledgeable of all regulatory and operative aspects relevant to clinical studies assigned, including applicable countries(ies). Will update management on the regulation(s) for the application process in the applicable country(ies).

Clinical Document Specialist (Contract)

Promedior (on behalf of Biobridges) Aug 2016 – Nov 2016

·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.

Clinical Supply Chain Administrator (Contract)

Boston Scientific (on behalf of Manpower) Jan 2016-Apr 2016

·Ensured clinical supply chain records and related documentation were 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.

·Performed document management and administrative tasks that support Clinical device planning, communication, distribution, tracking, reconciliation and record management.

·Ran reports from the Clinical Device Management System (DMS) and other systems as needed.

·Created and maintained status tracking information for various device-related activities, such as site readiness, training completions, pending returns, outstanding data remediation tasks, etc.

·Assisted as directed with system account management and related record keeping, (e.g., SharePoint access, DMS access, training records).

·Escalated issues and potential risk to trial and CSC management when warranted.

Records Electronic Management (Contract)

Biogen/Idec (on behalf of PhlexGlobal Ltd/Kelly Services/Atrium Staffing)

Dec 2011-June 2013

·Ensured the maintenance, accuracy and completeness of physical paper and electronic central clinical files (TMF) 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.

·Oversaw audit preparation of documents when necessary. Provided relevant training to Clinical Operations Staff.

·Organized, prepared, and maintained offsite archives.

·Assisted with developing records management policies and best practices in compliance with corporate, legal, and regulatory requirements.

·Represented R&D Records Management and Archiving in inter-organizational meetings and functional teams.

·Interacted with cross functional areas and external personnel, including supply, software vendors and records retention management (Iron Mountain).

·Initiated R&D Documentation and Archiving and participated in implementing action plans for improvements within R&D

·Organized department and inter-department meetings and training.

·Trained and supervised new employees.

·Interacted collaboratively in a team environment.

·Maintained quality through Good Documentation Processes.

Clinical Study Coordinator (Contract)

DePuy (on behalf of Mindlance, Inc.) March 2011 – June 2011

·Ensured compliance with company record retention policy through organization & maintenance of remote & on-site clinical trial documentation, including TMF for sponsor and investigator led studies.

·Created and maintained sponsor research binders containing clinical research protocols, consent forms, agreements, ongoing correspondence, financial information, and device tracking information in accordance with Regulatory guidelines.

·Received, tracked, and managed clinical trial data from study sites, as well as performed data entry and discrepancy management for clinical trials. Performed 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 databases, tracking expiration dates, generating purchase orders, processing invoices, and following up on issued checks and bank drafts. Maintained Clinical portion of Health Care Compliance database.

·Coordination of electronic Investigational and training meetings for Global Clinical Research Department.

·Assisted Sr. Administrative Assistant in the development, tracking, and maintenance of training records for all members of the Clinical department. Demonstrated the ability to effectively communicate, verbally and in writing, with internal and external customers at multiple levels.

·Assisted in efforts to prepare for Clinical trial monitoring visits.

·Performed administrative tasks and provided ad hoc support to the Worldwide Director and other Clinical research department members as needed.

Product Complaint Associate I

Cytyc/Hologic, Inc. Apr 2008 – Jan 2010

·Knowledge of the Quality System Regulation (FDA QSR 21 CFR Part 820) and ISO 9001 Quality System standard.

·Determined whether complaints were categorized appropriately for Potential Adverse Event and MDR reporting.

·Reviewed customer and technical support call information to determine complaint investigation requirements and look for trends in complaints.

·Assessed complaints and assigned complaint investigators.

·Assisted in validation of the complaint handling software, Trackwise.

·Participated in process improvements within the complaint handling process.

Clinical Research Associate I

Stryker Biotech Mar 2004 – Feb 2008

·Prepared and collected study related documents, including Regulatory documentation and patient source documents. Created and maintained Trial Master Files. Ensured compliance with ICH Guidelines for Good Clinical Practice, the Code of Federal Regulations, and study-specific protocol requirements.

·Interfaced with the Pharmacovigilance Department and obtained outstanding safety information from study sites. Performed 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, and concomitant medications.

·Performed data entry of Case Report Forms into clinical study databases and performed Quality Assurance for Data Management. Determined Visual Analog Scores.

·Assisted in performing yearly audits on Contract Research Organizations.

·Prepared and requested Regulatory documents from sites, tracked patient visits, and followed up with sites to collect outstanding Case Report Forms. Coordinated and tracked billing between study sites/institutions and Accounts Payable.

·Screened patients to determine eligibility for study specific protocols. Evaluated and selected Principal Investigators, clinical study sites, Contract Research Organizations, and outside vendors. Researched FDA Department Listing for restricted investigators. Serve as secondary contact for Pivotal and Pilot clinical trials.

·Assisted in Case Report Form design and development, instituted internal guidance documents, and participated in drafting Standard Operating Procedures.

·Maintained departmental training records and Regulatory agency contact logs. Distributed monthly reports on current clinical studies and developed quarterly newsletters regarding ongoing clinical studies.

·Daily responsibilities included support to Regulatory Affairs/Clinical Affairs, and direct support to the Director and Vice President of Regulatory Affairs and Clinical Operations. Interviewed candidates and supervised contract/temporary employees.

·Additional tasks included photocopying, filing, scanning, editing/proofreading documents, typing/data entry, and ordering necessary supplies. Maintaining departmental calendar, scheduled onsite and offsite meetings, coordinated travel arrangements, and provided reception and switchboard coverage. Performed special projects, as assigned.

eTMF Software

RADAR

SureClinical

Wingspan

Veeva Vault

Education

Montachusett Regional Vocational Technical School, Fitchburg, MA

Certificate in Medical Assisting

1983-1987

Fisher College, Fitchburg, MA

1993-1995, Liberal Arts Major

Becker College, West Boylston, MA

1994, Fundamentals of Pharmacy

CRA & CRC Beginner Program, Barnett Educational Services – Natick, MA (USA), 2006

Adverse Events: Managing & Reporting for Medical Devices, Barnett Educational Services – Mahwah, NJ (USA), 2006

Medical Device Monitoring, Medical Research Management, Inc. – Raynham, MA (USA), 2011

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