Management Data Entry

Silena A. Porch

*** ******** *** **** * • Waukegan, IL 60085• 847-***-**** • ***********@*****.*** • linkedin.com/in/silena-porch-97972070

PROFILE:

Motivated, results-oriented Professional with extensive clinical and regulatory knowledge (Good Clinical Practices, Food and Drug Administration, The International Conference on Harmonization and other regulatory requirements), has 16 years experience in clinical support activities with a broad array of clinical database software programs. Possesses exceptional interpersonal skills to develop and foster working relationships with people across all levels of the organization. Exhibits meticulous attention to detail and has strong organizational skills. Significant experience in the pharmaceutical industry, with proven follow through abilities.

EDUCATION:

College of Lake County, Grayslake, IL 1993

Associate of Science (AS) Degree

TECHNICAL PROFICIENCY:

Veeva, GSQA, eDocs, eCTD, ISI Toolbox, Documentum, Publisher, Microsoft Outlook, Product Vision, Records Management System, MS Excel

RELEVANT EXPERIENCE:

A Document Management Specialist with experience supporting document control, trouble shooting, advised, and followed up on study progress, and compliance within Pharmaceutical and Medical Device industries.

Reviewed all essential documents/contracts to ensure completeness, accurate and compliance with applicable company SOPs, regulatory and FDA requirements.

Support the development, review, editing, and management of controlled documents to ensure accuracy and usability.

Experience maintaining Documentum document management system to manage formula management product specification, and clinical research data for document submission processes.

Collaborate with international business units to research, compile, and manage essential documents for audits and clinical operations.

Support document change control; ensuring compliance with document management policies, procedures, and best practices.

Followed all applicable Standard Operating Procedures and Quality Assurance/Quality Control procedures.

EMPLOYMENT EXPERIENCE:

Document Control Specialist

Pinnacle Biologics, Chicago, IL 2016 – Current

Create, write, and manage records associated with Change Control, Labeling, Supplier Quality, Product Complaints, and CAPA.

Oversee the company training system, ensuring that all employees are trained to the necessary SOP’s.

Ensure that time-sensitive files are completed within the required timeframe.

Create and maintain official document files, ensuring that files contain all necessary information.

Project Associate

inVentiv Health Clinical, Gurnee, IL 2016

Developed and maintained spreadsheets used to track data and study activities.

Tracked, logged, and reported on incoming data, study documents, and inVentiv Health Clinical-own materials.

Verified study documents are reviewed and tracked for completeness and accuracy.

Held various contract positions from 2004 through 2016

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Study Document Coordinator

Randstad Pharma – (Takeda Pharmaceuticals), Gurnee, IL 2012 – 2016

Participated in document control, quality, and compliance; supported the development, review, editing, and management of controlled documents to ensure accuracy and usability.

Maintained various document management systems to manage label management, product specification, and audit data.

Maintained orderliness, safety and security of Company Records and processed requests for physical records by users.

Formula & Document Management Systems Coordinator

Info Tree Services – (PepsiCo, Barrington IL),

Communicated with outside vendors both domestic and international

Assisted Company’s ingredient vendors with different software programs: Product Vision and Documentum applications related to specification and formula management for data and document submission

Liaison between Product Development and Regulatory teams and vendors for issue resolution

Regulatory Registration Management Coordinator

Collaborative, LLC (AbbVie Inc., North Chicago, IL),

Maintained and supported various document management systems and team: registration management and regulatory affairs data with day to day activities including, but not limited: RM data entry, data evaluation, and assessment of processes.

Supported document change control; ensuring compliance with document management policies, procedures, and best practices and updated global databases.

Documentation Gathering Analyst

Experis/NNE (Hospira, Lake Forest, IL),

Maintained various document management systems to manage microbiology, regulatory affairs, and test data.

Organized all gap assessments for test method related regulatory submissions, analytical and microbiological test methods and stability protocols.

Organized completed technical gap assessment procedures that required evaluation of documents and comparison of test methods to source documents.

Prepared documentation of gap assessments and product summary packets for filing electronically or in paper format within client document control systems.

Clinical Document Specialist II

Manpower (Abbott/AbbVie Inc., North Chicago, IL), Waukegan, IL

Received/retrieved documents from the Clinical Research Specialist, Clinical Study Assistant, and/or Clinical Research Organizations and managed Trial Master File ensuring files were correct, complete, and consistent with Abbott/AbbVie’s SOPs and regulatory requirements.

Created content for Clinical Study Report appendices and provided accurate progress reports on collection of study-specific documentation.

Ensured scanned documents were available for author/medical writing review per study timelines; managed and archived paper case report forms.

Sr. CMF Associate

Randstad Pharma (Astellas, Northbrook, IL),

Managed electronic and hard copy Trial Master File repositories.

Established classification, submission, indexing, data entry, filing requirements, and conducted CDEx database searches.

Participated in auditing, reconciliation, and archiving of the Trial Master File.

Clinical Support Coordinator 2007 – 2012

Lundbeck, Inc. (Formerly Ovation Pharmaceuticals, Inc.), Deerfield, IL

Maintained Documentum document management systems to manage clinical management and compliance data.

Coordinated and ensured the timely collection, maintenance, filing, and tracking of study documentation in keeping with established timelines.

Liaised with Contract Research Organizations in the collection of study-specific documentation necessary for timely drug release and maintained literature reference database.

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