E. Timby*

Estelle P. Timby

Collegeville, PA ****6 484-***-**** e-mail:ad2nsg@r.postjobfree.com

EDUCATION:

Montgomery County Community College

Continuing Education Program: Certificate of Completion in Medical Terminology Pennsylvania State University

Fundamentals of Human Resources Management Certification Delaware County Community College

Associate Degree Program: 31 credits towards Associates Degree American Management Association

Continuing Education Program: Managing Competing Priorities in Today’s Workplace ICH/GCP Certification Delaware County Technical School, Aston, PA

Diploma Commercial Art and Design 2 year diploma

SUMMARY:

One year Clinical Contracts Associate II with over 15 years’ experience in the Biotech field, including more than 5 years as a TMF Compliance Specialist, demonstrated accomplishments, as an analytical thinker, a quick learner with the ability to multitask. A team player with strong organizational, interpersonal soft skills, who has proven to be diligent and hard-working. Computer Skills and Systems:

Adobe Acrobat Pro DC, Microsoft Access, Microsoft Teams, GXRS

MasterControl SharePoint, Microsoft Excel, Microsoft Visio, LIMS

MasterControl CTMS, Microsoft OneNote, Microsoft Word, SAP Concur

Veeva Vault CTMS, Microsoft Outlook, Oracle PeopleSoft, Trial Interactive

Windows Professional, Microsoft PowerPoint, EDMS, 55 to 60 WPM PROFESSIONAL EXPERIENCE:

CLINICAL CONTRACTS ASSOCIATE II (contractor)

Feb. 2023 to Present

GILEAD PHARMACEUTICAL/Intelliswift, Foster City, CA

Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements

Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of DMT’s records management/TMF archival initiative

Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in legal archive, Apttus, and eTMF GDAR system)

Data mining/modeling (e.g. statistical models) and enhancing data collection procedures to identify patterns and extract knowledge from large data sets

Processing, cleansing, and verifying the integrity of data used for analysis

Doing ad-hoc analysis of department data and presenting results in a clear manner

Work with management to manage business continuity procedures, including management of paper agreements

Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing

Collaborate with management to generate central intake report on a daily and published in a timely fashion E. Timby2

Responsible for keeping DMT Master Inventory up to date and accurate

Evaluate regulatory and DMT business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all

Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing

File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing

Ensure record filing is kept up to date is performed accurately by DMT members

Work with management to develop and maintain quality assurance and control plans

Responsible for monitoring accuracy of the team’s work by providing reports and metrics to management team

Potential lead of assigned meetings/projects and will mentor/help more junior staff with complex projects

Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents

Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records

Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with DMT Clinical Records team to ensure proper process is in place for off-site archival of paper agreements

Collaborate and partner with the Information Technology (IT) GDAR Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies

Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)

Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing

Contribute to the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and 30 day contemporaneous filing requirements and SLA turnaround time in eTMF (GDAR) and Apttus

Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus

Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.

Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival

Ensure appropriate documentation completed to track archival of files

Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF

Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad-hoc basis as requested by management DOCUMENT MANAGEMENT SPECIALIST

Nov. 2021 to Jul. 2022

WEST PHARMACEUTICAL, Exton, PA

Manage the Analytical Services documentation to ensure compliance with documents, laboratory notebooks, raw data, protocols, and reports

Independently facilitate routing of control led documents, including formatting, overseeing the review and approval process, tracking, and issuing document numbers

Manage Document retention and destruction/ Iron Mountain, completing transmittal sheets

Recalling Project boxes back from Iron Mountain direct via Internet

Consults with end-users to identify problems in accessing electronic content

Expert knowledge/use of Microsoft Word to review, quality check, and produce deliverables in a consistent, attractive, and timely manner

Updated styles, work with automated fields (e.g., Quick Parts, tables of contents), format recurring headers and footers, program links, leverage section breaks, etc.

Proofread the documents for formatting, clarify and correctness working with the technical staff to resolve issues

Responsible for the collection, issuance, and destruction of personal, instrument and preformatted notebooks

Provide support for all types of audits including regulatory, customer and quality system audits as appropriate, take initiatives to improve the effectiveness and/ or efficiency of lab processes

Conforms with and abides by all regulations, policies, work procedures, instructions, and all safety rules SENIOR TRIAL MASTER FILE COMPLIANCE SPECIALIST

Sep. 2020 to Nov 2021

SYNEOS HEALTH Blue Bell, PA

Knowledgeable of study team/client specific reference materials related to TMF documentation

Create and cross reference remediation tools/trackers that have been developed in order to complete a remediation

Experienced in electronic document management systems, Sharepoint, WebEx, and other applications as needed

Investigate and resolve document issues and escalate situations according to TMF Remediation processes E. Timby3

Assist the clinical study teams with the understanding of applicable document specifications and resolution of document/ data entry issues

Creating Global Information Management Programs

Creating Global Enterprise information Management Retention schedules and Policies

Global Taxonomy and Regulatory and Business Compliance Efforts

Act as a Business Analyst to develop, implement and manage content information processes, policies and procedures

Perform document process activities such as re-classifying, deleting duplicate documents, editing metadata and adding placeholders for missing documents

Identify, review and resolve document filing quality issues

Identify TMF risks / challenges to the PM and help resolve as applicable

Identify and resolve TMF trends/gaps

Ability to multitask, maintain high level of accuracy and attention to detail

Consistently deliver inspection ready databases on time while conforming to team expectations

Expert with TMF Reference Model (TMF Index)

Participate in leading and mentoring Compliance Specialist I’s and II’s

Generate reports within TMF based on assigned TMF tasks for compliance

Create expected document list using the TMF reference model with guidance from the TMF/Study team PMs TRIAL MASTER FILE SPECIALIST

Feb. 2, 2019 to Aug 2020

SYNEOS HEALTH Blue Bell, PA

Become familiar with study team/client specific reference Materials related to TMF documentation

Create and cross reference remediation tools/trackers that have been developed in order to complete remediation

Able to use tools such as electronic document management systems, Sharepoint WebEx, and other applications as needed

Investigate and resolve document issues and escalate situations according to TMF Remediation Processes

Assist the clinical study teams with the understanding of applicable document specifications and resolution of document/ data entry issues

Perform document process activities such as re-classifying, deleting duplicate documents, editing metadata and adding placeholders for missing documents

Identify, review and resolve document filing quality issues

Raise risks / challenges to the PM

Identify and resolve TMF trends/gaps

Ability to multitask, maintain high level of accuracy and attention to detail

Consistently deliver inspection ready databases on time while conforming to team expectation for complete content in the TMF

Ability to use and understand the TMF Reference Model (TMF Index) DOCUMENT MANAGEMENT SPECIALIST II

Nov. 8, 2016 to Feb. 1, 2019

SYNEOS HEALTH Blue Bell, PA

Become familiar with study team/client-supplied reference material.

Able to create and cross reference developed remediation tools/trackers in order to remediate Veeva eTMF.

Able to use tools such as Study Central, Shared Drive, WebEx, and other applications.

Investigate and resolve document issues and escalate situations according to eTMF Remediation department processes.

Assist the Project Managers and study teams with the understanding of applicable document specifications and resolution of document/ data entry issues.

Perform document process activities such as re-classifying, deleting duplicate documents and adding placeholders for missing items.

Identify, investigate and resolve document filing quality issues.

Raise risks / challenges to the PM

Identify and resolve document filing trending/gaps

Able to multitask and work independently

Consistently deliver inspection ready databases on time while conforming to team expectations for complete content in Veeva.

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