Data Management Clinical Document

EDGAR LOUIS BELSOM IV

646-***-**** *******@*****.***

PROFESSIONAL EXPERIENCE

NANOBIOTIX, New York, NY 2021 – Present

Manager, Medidata Administrator,

Create and manage study specific TMFs

Wrote the initial UAT for the implementation of the Medidata eTMF

Manage all upgrades and perform all System Administration responsibilities (UAT and System analysis for periodic improvements).

User Account Management, maintenance of system libraries and periodical system audits

Work with the Clinical Study Teams, leading the operational management of the CTMS and the Trial Master File (TMF).

Act as a liaison between end-user groups using the system and the system developer.

Lead the development of the CTMS User Training Plan and execute the plan after implementation

(internal and external).

Create and Update eTMF & CTMS Work Instructions.

Collaborate with vendor on the ongoing CTMS system issues, upgrades, and maintenance.

Create and communicate reports, updates/issues to stakeholders on a scheduled or necessary basis.

Work directly with the Clinical Study Teams, leading the operational management of the CTMS and the Trial Master File (TMF) with a focus on inspection readiness.

Act as Medidata Subject Master Expert (SME).

EASi (Contractor for Tesaro/GlaxoSmithKline), New York, NY 2019 – 2021 Clinical Document Specialist,

QC the Data Management Section of the TMF for completeness.

Review the Shared Drive for the Data Management TMF Documents.

Lead meetings with Data Managers and other study personnel to review TMF completeness of the Data Management section and resolve Gaps in the TMF.

Interface with CROs to QC offsite managed TMFs and resolve Gaps.

Correlate the Data Management documents in the Tesaro TMF Reference Model with the GlaxoSmithKline TMF Reference Model.

Upload documents to the TMF and make corrections when needed. PROGENICS, New York, NY 2015 – 2019

Clinical Document Control Specialist,

Manage and oversee all aspects of clinical document files (paper and electronic) including the scanning, filing and storage for all clinical programs.

Interface with vendors for transfer of trial master files, review and approval of workflows.

Ensure trial master files are structured to ascertain compliance with regulatory guidance and are inspection-ready at all times.

Generate, review and approve document control workflows with timeliness.

Scan, import and file documents received as per standard operating procedures. Edgar Louis Belsom IV Page 2

Conduct quality check of paper and electronic Trial Master Files to identify and remediate filing issues.

Author, Edit & Review TMF Management Plans.

Assist in the development of TMF and document storage SOPs

Maintain TMF workflow metrics.

Participates in resolving discrepancies found within documents as directed.

Assist is the preparation, conduct and resolution of internal TMF audits.

Lead employee training on TMF SOPs and TMF regulatory requirements. TRANSPERFECT, New York, NY 2015

Clinical Document Specialist,

QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies

Review Essential Document packages for completeness when required for Site Activation

Coding of documentation in Trial Interactive

Audits of client TMFs when contracted as well as internal TMF audits

Assist with User Acceptance Testing during product development and release

Work on cross functional teams including Project Management, Business Development Client Services, Development and IT on the implementation and management of client projects

Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to development team

Solutions, Project Management and Development to recommend new features and functionality to improve the product and reduce manual activities

Respond to client requests for new project initiatives. Collaborate with various members of the production and sales teams to assess the scope of work and produce cost estimates. FOREST LABORATORIES, INC., Jersey City, NJ 2012 – 2014 Operations Coordinator, Clinical Documents Information Center (CDIC), 2012-2014

(Respiratory)

Coordinated operations between CDIC and external imaging vendor to ensure transparent operations with zero document loss.

Provided customer guidance in the proper identification and classification of clinical records, facilitating the establishment of a complete and correct Trial Master File.

Assisted in the creation and testing of a prototype electronic Trial Master File which later served as a successful proof of concept for a true eTMF system.

Led training sessions in the use of the electronic Trial Master File prototype, establishing a skilled customer base across the affected departments.

Created a business solution for transfer of electronic files to a partner company in Europe which fulfilled the company’s obligation to provide reference images to our international partner.

Served as key point of contact (Program Lead) for all aspects of CDIC Operations for several study teams.

Analyzed digital documentation to ensure quality image references. Document Specialist Group Leader, CDIC, 2006-2012

(Respiratory)

Provided guidance and oversight to teammates on CDIC operational processes and standards. Edgar Louis Belsom IV Page 2

Created and organized digital reference copies of the Trial Master File.

Executed end user software test scripts for specialized life sciences/clinical digital image creation & management.

Managed the shipment of documents to an offsite long-term storage facility and continued maintenance of storage location records.

Document Specialist, CDIC, 2002-2006

(Respiratory)

Developed a prototype image reference system.

Assisted in the move and reorganization of all documents in the CDIC from the home office of Forest Laboratories, Inc. in Manhattan to a satellite location in Jersey City.

Authored abstracts for all documents in the Trial Master Files for multiple Clinical Studies.

Created a Trial Master File for multiple clinical studies.

Tracked information in both EDC & CTMS.

EDUCATION

Master of Library and Information Science, Louisiana State University, Baton Rouge, LA Bachelor of Arts in English, Louisiana State University, Baton Rouge, LA

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