Onyx Pharmaceuticals, South San Francisco, California

CAROLINA SUGIHARTO (707) 450-5088 http://www.sugiharto.com www.linkedin.com/in/csugiharto [email protected]

Skilled project manager with experience delivering both targeted and enterprise-wide solutions within the life sciences, high tech and telecommunications industries. MBA in Computer Information Systems, PMP, PMI-ACP and ITIL-certified and experienced in cGMP and 21 CFR Part 11 compliance.

EXPERIENCE

Onyx Pharmaceuticals, South San Francisco, California 2013 to Present IT Project Manager, R&D Manage delivery of R&D systems implementations with a focus on Regulatory Operations  Led Liquent Submission Registration implementation for Regulatory Operations group to on-time, on-budget completion, with hands-on responsibility for GxP validation activities.  Currently engaged in transition work streams supporting the Amgen/Onyx acquisition

Synarc, Newark, California 2007 to 2012 Senior Software Project Manager and Engineering Manager/Release Manager 2007 to 2012 Managed delivery of clinical trial application for oncology, DXA, osteoporosis, arthritis, orthopedic, cardiology and neurology therapeutic areas with cross-functional international teams  Managed numerous project deliverables, handoffs, issues and communications for assigned projects.  Worked with engineering management and clinical team (CPMs, CDMs, operations and scientists) to ensure revenue drove resource allocation prioritization and assessed impact to other study deliverable.  Effective project management of escalated engineering activities and timely communication of resolution action plans and status  Took on additional roles as needed when resources were scarce, such as SQA manager, database manager and release/technical writing manager  Effectively coordinated software releases and configuration deployments in accordance with processes defined in the approved SDLC  Managed the Technical Writing group and a Project Coordinator in the timely completion of technical documents to support Engineering’s SDLC.  Exercised judgment within broadly defined processes and practices to determine the best methods, techniques and evaluation criteria to obtain results and meet internal requirements. Clinical Project Manager II 2009 Managed clinical trial study from start-up to close-out in multiple countries with cross-functional study teams  Reviewed proposals for new business and provided input regarding feasibility and resources required to deliver services.  Supported department management by defining and improving clinical project management processes, including the preparation and update of relevant SOPs  Prepared financial and activity forecasts for revenue and capacity planning.  Managed all communications with the study sponsor regarding timelines and study-specific deliverables  Developed and maintained project plans encompassing all contracted deliverables, successfully tracking study pro gress and escalated issues

Varian Medical Systems, Palo Alto, California 2003 to 2007 Program Manager Managed treatment application and medical device projects (hardware/software) with teams of up to 50 members  Led cross-functional international teams and intradepartmental expectations to ensure program viability and succe ss.  Managed complex stakeholder expectations and communications.  510(k) clearance obtained from FDA within 45 days.  Transitioned mature R&D project to volume production line on schedule despite changing marketing requirements and a 50% staff reduction.  Interacted with internal and external auditors including FDA inspectors in relation to the design history file

DIRECTV BROADBAND, INC. (formerly Telocity, Inc.), Cupertino, California 1999 to 2003 Program Manager 2002 to 2003 Managed enterprise projects with teams of up to 30 delivering on IT and Product Development Projects.  Designed a targeted project management approach, including the creation of new guidelines and templates that contributed to on-time, under-budget delivery.  Worked on multiple enterprise projects with high business impact, complex requirements and multiple deliverables, timelines and customers.  Worked closely with business clients and engineering team during the design, implementation, QA, UAT, and roll out phases. Project Manager 2000 to 2002 Managed teams of up to twelve delivering on IT and Product Development projects  Interfaced with Marketing, Operations and Engineering to ensure incorporation of the new products, services, and LEC (Local Exchange Carriers) into day-to-day customer care and service provisioning operations.  Worked with training groups to ensure that personnel received timely instruction in the new business processes and that training materials accurately reflected required processes.  Developed a Project Website for SD&S group to effectively communicate the current project status to the organization.  Developed an online tracking mechanism that streamlined the process for the CRM change request. Information Specialist 1999 to 2000 Collected, analyzed and reported on customer data.

QSPACE, INC., San Francisco, California 1999 Database Analyst Designed, maintained and monitored customer database.

KREATIVA CIPTA ARTISTIKA, PT, Jakarta 1996 to 1997 Project Architect

TECHNICAL SKILLS Operating System: DOS, Windows, Basic Unix Programming: Microsoft Visual J++ 6.0, Microsoft Visual C++ 6.0, Visual Café, VB Script,.Net, Visual Basic Database: Microsoft Access, SQL Server 6.5, 7.0; Oracle SQL*Plus, ODBC; JDBC, Dbase III, Business Object 5.0, BO Web Intelligence, Broad Base Web Tools: Microsoft Visual Inter-Dev 6.0 (ASP/VB Script), Microsoft Front Page, HTML, ActiveX Control, Net Meeting, Web Trend, Join Me Application: Microsoft Word, Microsoft Excel, Lotus 123, Power Point, Adobe Premiere; Microsoft Photo Editor, AutoCAD R14, Business Object, Microsoft Project, Project Server, Visio, Microsoft Office, PVCS Tracker, eOn, CTI, DICOM, Rational Clear Quest, Requisite Pro, Rational SoDA, Mantis, , Liquent Insight, Metric Stream Document Control: Sharepoint, Docushare, Adobe Pro, Livelink, Path Wise, Compliance Wire CRM: Remedy, eAssist, Salesforce

EDUCATION and TRAINING MBA, Business Information Computer System, San Francisco State University, San Francisco, California BS, Architectural Engineering - Building Design, University of Tarumanagara, Jakarta, Indonesia PMP (Project Management Professional), PMI Project Management Institute, 2002 PMI-ACP (PMI-Agile Certified Practitioner), PMI Project Management Institute, 2014 ITIL-2011 Foundation Certification, 2013 Clinical Trial Design & Management certification, SFSU Extension, 2009 CPM (Certified Project and Program Management professional), San Jose State University, 2002  Liquent Insight Administration, RPT and Product Detail  Design Control Procedure per FDA Guideline: Management 5.0 Quality System Procedure for Medical Devices  IEC 60601-1 "3rd edition", ISO 14971:2000, IEC 62304  Business Object 5.0 Certification for Reporter, Designer, and Supervisor  DICOM Essential