Manager Project

Terry L. Gervelis

425-***-**** ********@*******.***

Summary of Qualifications

. A Records Manager with extensive expertise in managing all aspects of

clinical trial master files within the Pharmaceutical and Biotechnology

industries. Document control processing and maintaining records within

multiple industries.

. Dedicated to developing and streamlining procedures, which ensures

accuracy, timeliness, and accessibility of critical information in a cost

effective manner.

. Effective at working both independently and within a formal project team

structure.

. Highly detailed and organized.

. Strong work ethic focused on serving the customer.

. Recognized for high quality project completion on time and within budget.

Professional Experience

Bradson Technology Prof., Professional Staffing, Bellevue, WA

6/2010 -12/2010

Records Management Consultant @

Puget Sound Energy, Bellevue, WA re: SharePoint Document Control

Specialist

. Managed the repository that safeguards Critical Cyber Asset Information

(CCAI) and houses evidence that proves compliance with the NERC CIP

requirements the US Government issued in 2006 to protect the Bulk

Electric Grid.

. Managed SharePoint 2007 document control libraries.

. Developed process tools, collected supporting evidence and resolved

associated issues concluding in accurate archives.

Omeros, Pharmaceutical, Seattle, WA 2/2010 -

6/2010

Records Management Consultant

. Consulting resource for Clinical Department Trial Master File (TMF)

development.

. Maintained full lifecycle of TMF documents including metadata entry for

tracking resulting in easily retrievable information for FDA submission,

management decisions, and business processes.

. TMF trial document closeout audits resulting in high quality document

content and staging for internal or external review.

. Project staff supervision.

Bradson Technology Prof., Professional Staffing, Bellevue, WA

3/2009 -12/2009

Records Management Consultant @

Puget Sound Energy, Bellevue, WA re: SharePoint Document Control

Specialist

. Managed the NERC CIP repository.

. Managed SharePoint 2007 document control libraries.

. Developed process tools, collected supporting evidence and resolved

associated issues concluding in accurate archives.

Koronis Pharmaceuticals, Inc., Biotechnology, Redmond, WA 2007 - 2008

Document Control Manager

. Created and implemented the first document control systems for early

development-phase Biopharmaceutical Company in support of phase I-II

clinical trials, ensuring regulatory compliance of trials.

. Established, managed, and processed the Trial Master File (TMF), clinical

contracts, reference publications, and other shared department files.

Planned and implemented infrastructure build-out. Core responsibility.

. Supervised remote SOP team. Created filing and tracking systems for

standard operating procedure (SOP) records and training. Established a

SharePoint site workspace. Authored SOPs.

. Established and managed clinical study drug distribution systems.

Executed detailed tracking, packaging, and shipping per FDA regulations

in support of patient enrollment and dosing.

. Managed document flow as part of technology transfer process between drug

development partners and vendors.

ICOS Corporation, Pharmaceutical, Bothell, WA 2001 - 2007

Sr. Clinical Records Specialist 2005 - 2007

. Supported the record lifecycle of Clinical Trial Master Files (CTMF) and

managed clinical and/or record projects resulting from strategic

planning.

. Processed individual CTMF documents from acquisition through disposition

for phase I-III clinical trials. Core responsibility.

. Fulfilled Bibliography Coordinator responsibilities for Joint Venture

regulatory submissions.

. Managed vendor software upgrade project and in-house software

development.

. Conducted business process modeling, implemented change control

infrastructure, conducted feasibility assessments, and presented CTMF

training.

Clinical Records Specialist 2001 - 2005

. Maintained clinical trial master file system including lifecycle of

documents, internal and regulatory auditing, legal hold orders, and

litigation response. Core responsibility.

. Managed specific Clinical Records Department operations including

contracted staff and training. Created SOPs and working practice

documents (WPDs).

. Experienced EDMS (FileNet, OmniWeb, and Documentum) and MS Office

software user.

Education

Clinical Trials Certification, University of Washington, Seattle, WA

Project Management Certification, University of Washington, Seattle, WA

Records and Information Management Certification, ARMA, Lenexa, KS

Duquesne University, Pittsburgh, PA

Professional Development

ARMA Association of Records Managers and Administrators: Member

PMI Project Management Institute: Member

? Professional Conferences, ICH/GCP Training, ISO auditor

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