Julie L. Heck

**** ****** ***

Phone: 203-***-****

Cincinnati, OH 45243

Email: adjde7@r.postjobfree.com

PROFILE

A technical IT manager with over 20 years of progressive responsibility and a background of successfully leading dispersed, cross functional teams in a variety of projects and platforms through a rapidly changing environment.

TECHNICAL SKILLS

Project Management: Project Initiation, Requirements Gathering, Budgeting, Execution, Training, Software Configuration, Risk Assessments, Quality Assurance Process, and Agile

Operating Systems: Windows, CITRIX, Linux and UNIX

Regulatory and Clinical Applications: Oracle Clinical, Oracle Clinical RDC, Oracle Clinical TMS, Baseline Plus, Oracle Clinical One, TrialMaster, Medidata Rave, CRF WorkManager, Oracle InForm, and IMPACT

Other Applications: TOAD, DBeaver, JIRA, Microsoft Teams, Collibra, TrackWise, Opswise, ServiceNow, Documentum, Livelink, APIs, and SharePoint

PROFESSIONAL EXPERIENCE

Syneos Health · Cincinnati, OH Aug 2007 – Present

Syneos Health is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries.

Principal Engineer I (Technical Manager), Information Technology

Member of the Change Approval Board.

Manage a team of 8 developers and support personnel.

Manage coding system budget of over $250,000.

Managing the migration of critical clinical systems to supported versions and improving security of these applications.

Brought Oracle InForm development system in house to save $150,000 per year in hosting costs and decreasing the time to setup a new study by two weeks.

Managed the creation of a Biometrics dashboard.

Managed a project to implement versioning for our medical and drug dictionaries for the in-house Oracle Clinical system. This will reduce the time it takes to code by retaining coding for unchanged terms when upgraded to a new version.

Responsible for bidding and the bid defense of Clinical Data Management projects.

Managed the implementation and validation of TrialMaster, Medidata Rave, Oracle InForm, and Perceptive Data Labs at hosted facilities.

Managing support tasks to ensure that production systems issues are resolved within the service level agreement.

Maintaining compliance through the use of SOPs and other procedures where risks could not be reduced by automation.

MedImmune · Gaithersburg MD Aug 2005 – Aug 2007

MedImmune was a publically traded manufacturer and developer of bio-pharmaceuticals in the US that was purchased in 2007 by AstraZeneca.

Manager, Regulatory Business Analyst

Implementation manager for the regulatory department needs.

Planned and implemented a company-wide process to determine what documents to convert into an electronic archive, the process for the conversion, and the creation of a scanning department to support the conversion process.

Planned and managed the implementation and validation of InSight Publisher and eCTD processes to enable electronic submission to the FDA.

Planned and managed the implementation and validation of CoreDossier v5.3 upgrade from CoreDossier v3.

Planned and managed the project to create reports to track the distribution and destruction of product from SAP.

ArisGlobal · Stamford CT Jan 2005 – Apr 2005

ArisGlobal is a private developer of life sciences software for improved compliance, communication and collaboration.

Project Manager

Managed and planned the implementation of Register software and customizations for customers.

Developed training materials and training plans.

Coordinated software release schedule with client needs.

Assisted in troubleshooting Register issues at various clients.

Purdue Pharma · Stamford CT May 2001 – Dec 2004

Purdue Pharma is the largest private manufacturer and developer of pharmaceuticals in the US with revenue in excess of $1.5 billion.

Systems Analyst

Managed and planned the budgeting and expense of $3.0 million. Eliminated prior budget overruns of 8.3%. Implemented regular reconcilement meetings with business owners and IT executives.

Reduced expenditures by over $325k. Provided training to in house personnel reducing consulting costs for 5i migration from Documentum EDMS 98 and negotiations for CRF and Document Scanning services.

Oversaw the implementation of a Documentum 4i Submission DocBase. Installed Documentum Desktop 5 and CoreDossier v5 on a CITRIX environment creating a closed system enabling efficient deployment in 9 locations globally and reducing delays when providing future upgrades.

Developed IT Gold Standard process. Recruited Technical Services Organization (TSO) personnel into the production support team. This inclusion improves customer support by providing an “expert” to the TSO who helped perform Installation Qualifications and is able to take ownership of the system.

Project Manager for multi-site team of developers for the purpose of normalizing data, creating audit capability and linking submissions with electronic documents. Instituted regular videoconferences and timing trips between international sites at critical points. Resulting in seamless integration of code between US & UK and an XML feed to create an Executive Project Dashboard and Portal integrating with a Documentum 5 DocBase.

Wrote Service Catalogs for production systems replacing inadequate user documentation resulting in a decrease of 15% of calls to TSO.

Solvay Pharmaceuticals · Atlanta GA Mar 2000 – May 2001

Solvay Pharmaceuticals is an international chemical and pharmaceutical with annual revenue of 10.5€ Billion.

Sr. Programmer Analyst

International IT Coordinator responsible for budgeting, timeline and personnel for the customization, debugging and upgrade of Documentum and CoreDossier Systems in Germany, Netherlands and the USA. Achieved compliance and system compatibility while remaining under budget at all sites.

Retrospectively validated customized Software systems. Planned migration to a fully validated 4i platform.

Oversaw the successful replication in multi-national project for the instantaneous sharing of documents globally.

Lead project implementation team for the migration to 4i. Developed customized 4i test environment for GAP purposes. Merged SOP and submission document storage systems. Merger reduced the support needs by 50% and allowed for redundant server to be used for backup saving $130,000.

BV Solutions Group ( a Black & Veatch Company) · Overland Park, KS Mar 1998 – Mar 2000

Private consulting and engineering firm with revenue in excess of $2.0 Billion

EDM Systems Analyst

Project manager for the creation of a training tracking system. Leveraged existing technology; Documentum, ASP and Oracle Forms thereby completing the project on time and under budget.

Team Leader for Y2K upgrade implementation. Project required migration, testing and validation of 17 Documentum platforms.

EDMS customization team leader for 3 Gorges Dam project in China. Oversaw customized replication, attributes and security ensuring appropriate access for internal and external clients to critical documents.

System Administrator for Document Management Systems for numerous servers and workstations running Sun Solaris and Windows NT.

Analyzed, created and implemented complete Software Product Life Cycle documentation including test scenarios, test plans, scripts, user manuals and QA analysis.

EDUCATION

Bachelors of General Studies – Environmental Science Certificate, 1996

Indiana University, Bloomington, IN

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