Onyx Pharmaceuticals, South San Francisco, California
CAROLINA SUGIHARTO
(707) 450-5088
http://www.sugiharto.com
www.linkedin.com/in/csugiharto
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 progress 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 success.
· 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 2002Managed 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 2000Collected, analyzed and reported on customer data.
QSPACE, INC., San Francisco, California / 1999Database Analyst
Designed, maintained and monitored customer database.
KREATIVA CIPTA ARTISTIKA, PT, Jakarta / 1996 to 1997Project Architect
TECHNICAL SKILLS
Operating System: / DOS, Windows, Basic UnixProgramming: / 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 Management 5.0 / · Design Control Procedure per FDA Guideline: 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