Document Specialist Reimbursement

Tonya Pettis

(Remote Candidate) Philadelphia, PA 19138; Interviews: 24 hours’ notice; Start: Immediately; No planned vacations

Recruiter Summary:

Tonya is a seasoned Clinical Trial Associate with extensive experience in Document Management within the Pharmaceutical Industry. She has hands-on experience in preparing submission documents (individual documents and compound documents). She has strong experience in providing TMF/clinical study file documentation oversight and QC, Good Documentation Practice, Good Clinical Practice, and a strong understanding of the impact of the TMF on Trial Management. Additionally, she has expertise with RCAM and Documentum Document Management Systems. She is proficient with Microsoft Office products (e.g., Word, Excel, and SharePoint & PowerPoint). She is a remote candidate and available to start immediately.

Profile Overview:

Experienced Regulatory and Pharmaceutical Support Professional possessing excellent skills with content management, project coordination, and operations support with infectious diseases, women’s health, oncology, respiratory, and pediatrics indications. Strengths include:

Strong multitasking capabilities with proven expertise in prioritizing and meeting critical deadlines.

Excellent communication skills with the ability to relate to all levels of the organization.

Strong work ethic, sense of accountability, and initiative.

Education:

ABO Haven Incorporate, Philadelphia, PA October 2019

Certified Medical Reimbursement Specialist

Medical Billing and Coding Training Certificate

Strayer University, Philadelphia, PA Expected Graduation - December 2021

Bachelor of Sciences Degree in Business Management with a Concentration in Health Services

Community College of Philadelphia, Philadelphia, PA December 2010

Behavioral Health Certification

Professional Skills:

Computer:

Worldwide Information System for Document Management (WISDOM)

ISI Toolbox

Adobe Acrobat

SharePoint

Right Track II/BRIO

Insight

Inform

SAP

ARIBA

eDX

Microsoft Office Suite

Reference Manager

C.A.R.S

RCAM

ERIS

Outlook Email

Regulatory Forms Management:

Investigative Review Board Approval Letters (IRB)

PSURs – Patient Safety and Narratives/Periodic Safety Updates

Team Rosters and Training Records for Team Personnel

CV’s

Investigator Licensures

FDA 1572’s

Investigator Brochures (IB’s)

Trial Master File - Repository

SKYPE First Doc and Documentum Document Management Systems

Informed Consent Forms

Normal Lab Values

Invoices

Laboratory Certifications

Financial Disclosure

Protocols

SAGE

Professional Experience:

Reason for the gap in employment Looking for potential opportunities

Content Management Specialist

Radiant Systems, Deloitte, Princeton, NJ February 2020 to April 2020

Worked with Global Audit & Assurance business stakeholders to maintain and publish technical materials to research platforms. Those materials are used by the auditors to execute high-quality Audit and Assurance engagements. The role includes:

Coordinated and executed the publication of technical materials

Partnered with global transformation initiatives to determine how to structure and deploy their solutions

Worked with technology teams on the transition to the next generation content solution

Self-directed, comfortable working independently and without daily supervision

Ability to productively manage and work within an onsite and a virtual team

Strong English communication skills (written, verbal, and presentation)

Proficiency in Microsoft Office products (e.g., Word, Excel & PowerPoint)

Knowledge management experience and writing, revising including gathering and releasing content

Experienced with enterprise content management platforms such as SDL or Documentum

Audit & Assurance Products & Solutions directly support engagements and the continued transformation of the content that is used by all Deloitte Audit Practitioners in the execution of Audit & Assurance engagements around the globe.

Coordinated with global and member firm stakeholders to publish new and updated content, which may be localized for each Global Audit & Assurance business.

TMF QC Associate

Clinlogix, LLC September 2019 to November 2019

ClinSearch Resources, Spring House, PA

Worked with clinical trial data and documents (electronic) to ensure it was sorted and recorded in the appropriate fie locations.

Processed trial documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WI), ICH-GCP guidelines and study-specific TMF Plans.

Collected data from various documents and entered the electronic clinical trial management system (e.g., SharePoint).

Assisted with updating and maintaining study management documents such as trackers and logs.

Performed precise quality review of trial documents submitted for entry into the TMF and liaised with project teams to resolve any issues identified.

Transcribed and/or renamed data according to each study-specific naming convention.

Retrieved documents and data for the project team to assess for completeness, accuracy, and errors.

Ensured the security, compliance, and confidentiality of all documents related to active and archived projects.

Provided the project team with any updates on the regulatory document collection status for the trial.

Reason for the gap in employment Took some time off due to some medical reasons

Clinical Support Specialist

Glaxo Smith Kline December 2016 to January 2019

Novella Clinical – Division of IQVIA Quintiles, Collegeville, PA

Supported the harmonization of Electronic Trial Master File (eTMF) from numerous electronic document management systems into the Electronic Document Exchange (eDX).

Provided support to the Document Management Control group ensuring accuracy and consistency of documents required for the Trial Master File (TMF).Worked on complex or multiple project assignments.

Demonstrated ability to manage projects and assignments with minimal supervision.

Managed projects from start to finish and trained new-hired staff and co-workers with the C.A.R.S Repository Document Management System.

Document Specialist

Janssen Pharmaceutical April 2016 to November 2016

PRA Health Sciences, Spring House, PA

Based remotely, prepared submission documents (individual documents and compound documents).

Provided advanced publishing services of complex documents using industry-standard publishing tools, included submission-ready formatting, hyper-linking and bookmarking.

Provided document management services, which included electronic document secure storage in the (ERIS) submissions document repository; indexing and archiving of approved documents in accordance with quality standards. Performed technical QC.

Document Specialist

Glaxo Smith Kline October 2015 to February 2016

inVentiv Health Clinical, Collegeville, PA

Utilize knowledge of regulatory submission requirements, processes, and procedures, with Wingspan eREG

Structure/ format, associated GSK systems, and software to ensure teams meet submission dates.

Electronic Document Specialist

Teva Pharmaceutical Company May 2014 to July 2015

JOULE Clinical Staffing Solutions, West Chester, PA

Assisted with electronic report processing for eCTD submissions within the Nonclinical Writing Department.

External PDF reports are checked and brought into compliance with standards.

Internal reports in Microsoft Word will be formatted to comply with an internal style guide.

Also, import completed reports and references into the SAGE EDMS.

Publishing Technician

Merck and Company January 2013 to February 2014

PAREXEL, International – Clinical Research Organization, Horsham, PA

Worked remotely and assisted in the production of basic publishing services submissions and delivery of regulatory services in accordance with defined agency guidelines, and balanced the quality and timeliness of customer deliverables.

Applied submission formats and redactions to simple documents and submissions and used ISI Toolbox in Adobe Acrobat.

RCAM and Documentum Document Management Systems.

Interacted with all levels of management regarding major submission documentation status/issues and participated in the submissions/reports document management process.

Clinical Trial Associate (CTA)

Pfizer Pharmaceutical Company October 2010 to October 2012

EXECUPHARM, Trooper, PA

Was responsible for liaising with Study Teams and executing assigned tasks to ensure project deliverables are met.

Ensured TMF completeness and accuracy based on SOPs and regulatory requirements.

Provided TMF/clinical study file documentation oversight and QC, Good Documentation Practice, Good Clinical Practice, and a strong understanding of the impact of the TMF on Trial Management.

Possess good critical thinking skills with a focus on inspection readiness.

Content reviewed many documents in a short time frame while maintaining consistency and attention to detail.

Prioritized work accordingly to meet departmental needs and independently worked to meet deadlines.

Reviewed site TMF regulatory documents for ICH GCP and GDP compliance.

Reviewed internally generated TMF regulatory documents of ICH GCP and GDP compliance

Searched and uploaded documents into INFORM an EDMS/eTMF

Possessed understanding of records management best practices

Demonstrated ability to multi-task effectively

Interacted well with various team members and provided value-added support to projects

Displayed ability to independently solve routine problems following standard policies/procedures

Used technical knowledge and experience to work with the study manager and others to proactively identify and anticipate issues and develop workable solutions.

Liaise with outside vendors to ensure study deliverables were met.

For trials using external vendors contributed to documentation and set up activities to facilitate efficient workflow.

Supported investigator meeting preparation and collection/distribution of materials.

Maintained study information on a variety of databases, i.e., RAVE tracking information and preparing status reports. Reviewed for data inconsistencies within and across various databases. Took appropriate corrective actions to resolve issues that were identified.

Ordered clinical trial supplies, applied technical knowledge to recognize problems or delays.

Managed clinical, regulatory, and study-related documents; review documents for completeness, accuracy, and compliance with protocol and appropriate regulations.

Ensured all study documents were archived based on the appropriate guidelines/policy.

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