Kevin F. Shea

adv6wp@r.postjobfree.com

+1-610-***-****

Project/Program Manager guiding teams to pragmatic and impactful technology solutions

Professional Experience

Principal Consultant / Owner

04/2015 to Present

Driftpin Consultants

Ivyland, PA

Current Engagement: Head of Quality, CellPort Software, Exton, PA 07/2021 to Present

Services and Technology Expertise: Change Management, System Implementation, Program/Project Management, Solution Architecture, System Validation/Assurance, Clinical IT Risk Management

Domain Expertise: SaaS, Cloud Computing, Decentralized/Virtual Trials, Agile Software Development, Strategic Planning, Risk Analysis, Data Management, Clinical Technology, Call Center Ops, LIMS, EDC/CDMS/CTMS, Safety/PV

·Life sciences/digital healthcare consultancy applying risk-based approaches to technology initiatives: solution architecture, strategic road-mapping, TCO justification/management, KPI/metrics-based operational controls

·Advisory services across Preclinical, Clinical, Safety, and Medical Affairs/Med Info domains with a focus on client success, product road-mapping, stakeholder management, and operationalization of technology and workflows

·Specialize in client success implementing validated technology; team management, coordinating requirements, workflow process design and benchmarking, system integration, and change management

Senior Director, Clinical Solutions

12/2009 to 03/2015

C3i, Inc.

Morristown, NJ

·Established and grew a SaaS clinical technology practice for SMB clients, solution architecture of BPO services that improved the efficiency and quality of clinical trials for sponsors and site users

·Developed strategic initiatives in Risk-based Monitoring, digital health, and imaging clinical trial support; delineated services, analyzed revenue and market potential, resource planning, and external messaging

·Global Sales Lead, with services teams based in USA, Bulgaria, India, and China, responsible for operational integrity, continuous improvement, new business development, relationship management, and quality oversight

·Managed consultants in clinical development, clinical operations, clinical data management, quality management, computer system validation, and system implementation engagements

Director, eClinical Solutions

12/2008 to 09/2009

Business and Decision, Inc.

Wayne, PA

·Established a SaaS eClinical practice for SMB clients, built BPO Data Center for the Oracle Life Sciences suite

·Solution Architecture – Managed internal/external partner team delivering the Oracle Clinical – Siebel Clinical integration initiatives and developed go-to-market plans to ensure project success and to realize ROI

·Created unique value propositions through alignment with Compliance and QMS practices; crafting innovative, risk-based approaches for hosted SaaS implementations

Director, Clinical Technology and Data Management

01/2006 to 11/2008

RadPharm, Inc

Princeton, NJ

·Implemented and validated enterprise Oracle Clinical/RDC system for Imaging CRO

·Built and owned a Clinical Technology group, integrating it with the Clinical Data Management; managed both teams to enhance efficiencies, enhance sponsor satisfaction, reduce audit risk, and improve data quality

·Managed ClinOps business owner and IT relationship, aligned requirements, design, and solution; focus efforts to enhance KPIs; ROI and TCO analyses; change control management

·Enhanced strategic relationships with key sponsor/clients; rebuilt and improved customer confidence by driving quality improvements, focused on collaboration and communication with key sponsor personnel sponsor

Principal Technical Writer

01/2001 to 12/2005

Oracle Corporation – Pharmaceutical Applications

Burlington, MA

·Managed the development of technical documentation such as Release Notes, Installation Procedures/Requirements, Functional Design, and Technical Design specifications

·Member of the OC/RDC/TMS development team contributed to the creation of product launch processes and go-to-market strategies

·Participated in the UI/UX development, including tests, collection and analysis of results, and formulation of design change proposals

·Negotiated with internal groups to create new interface designs that satisfy user needs, technical specifications, and resource availability

Owner and Principal Technical Writer

1997 – 2000

Driftpin Consultants

LaCombe, LA

·Delivered online help systems, procedural manuals, software development/API, safety manuals, marketing copy

·Provided complete ownership of the document cycle, from inception to production

·Incorporated usability principles to enhance end-user comprehension, retention, and satisfaction

·Client list included: S&P, Shell Offshore, McGraw-Hill, ABB, The College Board, Oceaneering

Research Geologist/Scientific Diver

1995 – 1997

Naval Research Laboratory

Stennis Space Center, MS

·Researched and wrote peer-reviewed scientific articles and in-house technical manuals

·Utilized electron microscopy to study the textures and components of clay-bearing marine aggregates and sediment

·Developed Environmental Cell procedures and instrumentation for use in hi-vacuum TEM columns

·Participated in scientific research cruises as Research Geologist and Lead Scientific Diver

Class I Commercial Diver/Welder

1986 – 1995

Oceaneering International, Inc.

Morgan City, LA

·Excelled in dynamic, hazardous projects in high-risk environments; operations that demanded team leadership, reliance, adaptability, safety, and performance under pressure

·Specialized in structural hyperbaric wet and dry weld repair and marine construction, certified to perform permanent weldments on all classes of US Naval warships

·Expert in all phases of underwater construction, salvage, inspection, and repair in challenging and environmentally sensitive offshore and inshore marine environments

Citizenship: USA and Republic of Ireland

Education

BA Geology, Lafayette College, Easton, PA

MS Geological Oceanography, University of Southern Mississippi, Hattiesburg, MS (coursework complete)

Certificate in Clinical Trials, Boston University

Certificate in Project Management, Villanova University

Professional Associations

ISPE

Metrics Champion Consortium Ambassador

DIA

IEEE

American Association for the Advancement of Science

Society of Clinical Data Management

CDISC

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