Title: Our Siebel Clinical Team
1Our Siebel Clinical Team
2The Entire Team
.
Resources will be assigned according to skill
requirements and availability. Not all resources
above are assigned to one project.
3Parambir SinghSiebel Practice Director
- Large Pharma Company - Led a project to implement
a clinical trial management system (Siebel
Clinical). Led the process of performing an
internal needs analysis as well as a marketplace
assessment of packaged CTMS applications. Also,
led the implementation of Clinical this project
included design, configuration, testing,
conversion, interfaces, and deployment. This
implementation was deployed using an offshore
development capability and resulted in a high
quality validated CTMS solution for this
organization. - Global Contract Research Organization - Led this
project through the complete System Development
Life Cycle from Vendor selection and Design to
Deployment. Managed Siebel Clinical
implementation efforts, including gathering and
designing the functional requirements for the
system, coordinating the set up of the technical
architecture, and leading both the interface and
conversion teams to design, develop and deploy
multiple interfaces with internal financial and
patient recruitment systems and fully integrated
conversion system to convert entire studies from
legacy systems. Also led the post-implementation
design effort for 2 subsequent releases that
incorporated requirements gathering, cost
analysis, and high level and detailed design. - Global Pharma Company - Member of the Integration
team whose responsibilities included Design and
development of multiple interfaces from the
deployed Siebel 7.04 Clinical system to several
internal systems to coordinate clinical, finance,
and management related data. Conversion Lead
whose responsibilities included Gathering
conversion system requirements, and design and
development of conversion system to migrate
studies from 2 large legacy systems to the new
Siebel Clinical application. Assisted in
developing a post-migration support organization
for users on the converted studies.
Mr. Singh is Sr. Director of BioPharms Siebel
Practice and has been working in the industry for
over eight years, and focused on Siebel
implementations for over seven years. Parambir
is based in San Antonio, Texas and has been with
BioPharm since January, 2008. Parambirs
experience has been heavily focused on the
project management, business process design and
development / implementation of applications for
clinical trials management with an emphasis on
the Siebel Clinical solution. Throughout his
career, Parambir has been involved in several
Siebel Clinical implementations for a variety of
clients.
Parambir received his BS - Management Science
and Information Systems (MSIS) from Pennsylvania
State University in August of 1999.
4Duncan HallProject Manager
- Global Pharma Organization Creation of
strategies for Siebel Clinical training, users
acceptance testing and support. Creation of
training package for thousands of users and User
Acceptance Testing scripts and methodology. - Global Pharma Organization Project Manager for
implementation of Siebel Clinical. Management of
business process mapping and design workshops.
Ongoing business and management support. - Large Contract Research Organization Project
Manager for global implementation of Siebel
Clinical 7.3. Managed project through complete
developmental lifecycle from initial requirements
gatherings through to validation, training and
rollout. - Large Pharma Organization Project Manager for
the implementation of Siebel Clinical to replace
a plethora of home-grown management systems.
Managed eight resources. Provided both technical
and business guidance through the project. - Global Pharma Organization Managed the
development of systems to support their oncology
studies. Developed templates based on the
Summit-D methodology. Trained staff within the
organization to manage the system after
implementation.
Mr. Hall has been the President and Chief
Information Officer of Triumph Consultancy
Services since 2002. Throughout the last decade,
Duncan has held major leading software roles in
the Pharmaceutical and Automotive industries. He
also has some experience in clinical and
biometric operations. Over the last two years,
he has built this organization up to include
developers, testers, other project managers and
trainers as well as support staff for dedicated
to the implementation of Siebel Business
Applications. Manages overall resources, business
development, assistance with specifications and
proposal creation. Duncan resides in the United
Kingdom.
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Duncan graduated from Hull University in 1994
with a Masters degree in Engineering Design and
Manufacturing.
5Alice CrawfordSenior Consultant, Systems
Requirements Quality Assurance
- BioPharm Systems - A key member of our Siebel
Clinical Practice and participates in validation
and consulting activities for the National Cancer
Institute. Active member of the OCUG CTMS and
Safety and Validation focus groups and provides
21 CFR Part 11 consulting for our clients. - CTMS IT Firm Participated in the design
analysis and creation of the functional
specifications for development of the SiteMinder
and TrialMinder CTMS solutions. Developed,
managed and executed the testing methodology for
all products including the documentation for 21
CFR Part 11 compliance. Technical liaison between
clients and development teams. Created training
materials and provided on-site training sessions
for clients. Provided support and trouble
shooting for clients. Application expert for
trade shows and sales demonstrations. - Global Pharma Company - Developed an in-house
product evaluation group, including sensory
evaluation, for health care products.
Participated in the development of study design,
protocols and CRF design, supervised patient
recruitment, performed on-site study management
and quality assurance of received study
materials, reviewed adverse events and analyzed
data. Assisted in the development of clinical
SOPs, worked with marketing and claims and
provided regulatory consultation.
Ms. Crawford is a Senior Siebel Consultant. She
has been working in the industry for over fifteen
years, with a focus on Clinical Trial Management
Systems (CTMS) for the past nine years. Alice is
based in Memphis, Tennessee and has been with
BioPharm since March, 2004. Alices experience
has been centered on software development,
quality assurance, training and support of
various CTMS applications. Currently, Alice is
involved in several Siebel Clinical and other
CTMS implementations for a variety of clients.
She is also working on a development project with
the National Cancer Institute and performs gap
analyses and consultation for 21 CFR Part 11
compliance.
Alice received her BS in Biology from Rhodes
College in1981. She also received a Certificate
of Medical Technology from Vanderbilt University
Medical Center in 1982.
6Robert BolducSenior Consultant, Systems
Requirements
- Triumph Consultancy Firm Dually responsible for
overall business development and system
requirements for Siebel Clinical implementations.
Performing operational activities such as
resource allocation and financial budgeting.
Leading numerous clients requirements gathering
workshops on Siebel Clinical engagements. Acts as
the connection between client and design team.
Developing and managing testing and documentation
activities. Developing client custom reports
using a Crystal Enterprise application. - Global Pharma Company CTMS Instructor for all
clients and internal staff for Siebel Clinical.
Developed and maintained training materials. - Global Contract Research Organization - While
first joining this firm, Robert started out as a
CRA, then moved in the key positions surrounding
a large internal implementation of Siebel
Clinical that expanded over four years. Helped to
define system requirements and supported
requirements workshops with end users. Acted as
liaison between design and end user team to
ensure proper communication. Large involvement
with both the creation and execution of testing
scripts against system requirements. Both
developed training manuals and other knowledge
transfer materials as well as instructed end
users on the final product. Created reports using
a Crystal Enterprise application.
For the last six years, Mr. Bolduc has played a
role in many phases of implementation with Siebel
Clinical. He lives in North Carolina and has
worked as one of our Senior Contractors through
Triumph Consultancy Services since the middle of
2007. Robert is well versed in all aspects of
implementations for Siebel Clinical including
system design, defining user requirements,
testing and training as well as developing custom
reports. He understands the importance of
customer satisfaction and continued business
operations through his recent experience as a
Business Developer.
Robert received his BS Science in Electrical
Engineering from Pennsylvania State University in
2001.
7Chad FinchConsultant, Senior Developer
Mr. Finch uses his technical abilities to help
design and implement solutions. He has been a
part of teams that design systems, with the use
of Microsoft programming languages, to increase
computer automation and human efficiencies. He
has nearly eight years of experience leading
Siebel Clinical programming efforts. Chad lives
in North Carolina and works as a Consultant with
Triumph Consultancy Services. He started with
this group during 2007.
- Triumph Consultancy Firm Team lead for
activities related to developing and implementing
business solutions. Providing development
expertise for Siebel Clinical configuration
including interfaces to related systems. - Large Contract Research Organizations Led
activities related to interfacing
interdepartmental and external systems with
Siebel Clinical. Designed, implemented and tested
custom technical solutions for large clinical
studies using a wide variety of software.
Partnered with business representatives to create
and present proposed solutions to all levels of
management. Specific involvement with
investigator payments, payments, custom
reporting, and enhanced user interface. Reduced
study setup time by using programming query
languages to solve complex reporting
requirements. - Large Contract Research Organizations Senior
Business Analyst where he designed and produced
production and ad hoc reports for a national help
desk. Worked with Office database and spreadsheet
applications to increase reporting time and
reduce required support staff. Standardizing open
database connectivity (ODBC) driver
configurations to eliminate connectivity issues.
Chad graduated in 1991 at the North Carolina
State University with a BS in Arts and Business
Management.
8Anthony Kastle Consultant, Senior Developer
Mr. Kastle has dynamic technical skills and
experience in the software development lifecycle
phase for CTMS. Since his completion of
undergraduate school, Anthony has been involved
with software development, specializing in
development and configuration of CTMS over the
last seven years. Anthony currently resides in
North Carolina and works as a Consultant with
Triumph Consultancy Services. He has been working
there since the middle of 2007.
- Large Pharma Organization Consulted as an
expert in large Siebel Clinical 7.8 with a global
development team consisting of four different
groups Technical Architecture, Base Application,
Interfaces and Data Migration, on all aspects of
the software delivery process. Hands on Siebel
development of more complex configuration,
involving Business Services, Workflow and
eScript. Assisted with the implementation process
of six production environments. - Large Contract Research Organization Extensive
configuration on a Siebel Clinical 7.5
implementation, reconfigured many of the main
functionalities to fit client expectations
including payments, subject visits, recruitment
and monitoring visit reports. Led a team of six
software engineers. Developed an interface
between Siebel Clinical and the Lawson Financial
system. Worked closely with the support hotline,
resolving issues, while keeping the project on
track. Managed the maintenance of eleven
non-production environments with at least three
different versions. - Large Contract Research Organization
Development Team Leader with ClinTrack a
Clinical Trial Management system. Lead team of
four software engineers. Introduced best
practices and coding standards documents.
Maintained and created Oracle PL/SQL code
including procedures, triggers and database
release upgrade scripts. - Information Technology Firm Clinical Research
and Development firm capturing medical records
using pen-based technology. Led a team of eight
software engineers. Developed processes used by
developers to execute unit testing. Maintained
and created all Informix stored procedures
triggers, load files ad 4GL programs in UNIX,
including mentoring others.
Anthony received a BS in Computer Science with
Mathematics in 1994 at Wayne State University.
9Tammy Finnigan Senior Consultant, Trainer
Ms. Finnigan resides in the United Kingdom and
has been working in the field of creating and
executing training sessions for the last five
years. With this ability, she has directly
impacted organizations by increasing the number
of productive resources. She is a Senior
Consultant at Triumph, working there since
January 2007. Tammy has a well rounded background
in Clinical Research with experience in
management, monitoring and research with an
emphasis on training.
- Triumph Consultancy Firm - Training Specialist
for Triumph Consultancy Services has led teams of
training specialists to develop various cutting
edge training classes for global user
communities. - Large Contract Research Organization A part of
the global training department working closely
with Project Management and Clinical Operations.
Identified process improvements and training
needs of the user community and deployed
appropriate training methods and materials.
Developed standard CRA training in Europe,
Africa, Middle East and Australia. - Large Contract Research Organization Managed
twenty-one CRAs and Clinical Administrative staff
in the Scottish department. Developed in-house
training programs to increase CRAs ability to
meet organizational demands. - Large Contract Research Organization Joined the
Siebel Clinical implementation training team. - Large Contract Research Organization Acting as
Clinical Team Manager on global oncology trials.
Functional management of the clinical project
teams, including CRAs and clinical
administration, coordinating project status and
timelines, standardizing monitoring procedures
and implementing quality processes.
Tammy attended the University of Paisley in
Paisley, United Kingdom, graduating 1998.
10Laurel-Ann StrattonConsultant, Quality Assurance
- Large Pharma Organization Led the functional
team and directed the efforts for the analysis,
design, testing and deployment phases of Siebel
Clinical 7.8 implementation. Acted as the
functional SME for offshore IDC developers.
Interfaced between users, validation, and quality
assurance to ensure proper communication.
Developed user tools and training documents.
Oversaw the study migration coordination of
system databases utilized in Clinical Operations.
Worked as Database User Administrator for
multiple Clinical systems. - Large Pharma Organization Electronic Document
Management Systems (EDMS) Specialist managing
clinical documents for various study trials.
Reviewed site regulatory documents for
completeness and compliance with FDA and GCP
guidelines. Performed functions as necessary such
as running queries and reports as the Clinical
Operations Database Administrator. Managed
training programs for new hires and existing
departmental personnel. Wrote guidelines for
Standard Operating Procedures and work
instructions. Ensured all documents were
maintained in accordance with established
procedures and Good Clinical Practices (GCP)
requirements. -
Ms. Stratton has been dedicated to information
technology and clinical systems for nearly four
years. The last several years, she has been a key
member of a Siebel Clinical implementation team.
Laurel joined the BioPharm team during the fall
of 2007. She lives in San Diego, California
where she assists our Siebel Clinical team with
various aspects of testing, validation and SOP
development. She also helps clients better
understand the different modules and
functionality of Siebel Clinical.
Laurel received her Associates Johnson Wales
University in Rhodes Island during 1993.
11Davinder AujlaConsultant, Quality Assurance
Mr. Aujla transitioned from software development
into quality assurance during the first decade
after graduation. In those last seven years, he
has expanded international business skills by
working in multiple foreign countries such as
Australia and Singapore. More specifically,
Davinder has been in the pharmaceutical industry
since 2003. He lives in the United Kingdom as a
Consultant with Triumph. He joined the team at
the end of 2007.
- Large Pharma Organization Involved with user
acceptance testing, using Mercy Interactive Test
Director application for test script
documentation, and defeat logging and tracking.
Responsible for planning, scripting and execution
of User Acceptance Testing including tracking of
defects, prior to the rollout of their first
release of the web-based Siebel Clinical. - Large Contract Research Organization Designed
user acceptance, and performance qualification
test scripts, and test data for an interactive
voice response system which interfaced with
Siebel Clinical eBusiness application, workflow
automation enhancements, defect tracking and
retesting for several release versions. - EDC IT Firm Executed lifecycle software testing
using Mercury, JProfiler, JMeter, and bespoke
tool designed for automation testing. Ensured 21
CRF Part 11 compliance. Developed and maintained
procedural and guidelines documents. Created and
executed internal training.
Mr. Aujla graduated from Leeds Metropolitan
University in 1996 with a BS in Project
Management.
12Quinn RowlandConsultant, Trainer
With seven years experience, Ms. Rowland has been
training and providing support for Siebel
Clinical as well as other complex enterprise
systems for the last four years. She also has
extensive experience with industries outside
Pharmaceutical in the area of customer support
and training. Quinn lives in North Carolina and
works along with several members of the Triumph
team. She has been working with this organization
for two years.
- Triumph Consultancy Firm Providing training,
development, and support advice for Siebel
Clinical implementations. Developing in-house as
well as online training materials for global
rollout of Siebel Clinical. Delivering Siebel
Clinical training to various roles and
departments globally. Liaison between team and
upper management. - Large Contract Research Organizations Acted as
a CTMS support coordinator managing the U.S. team
responsible for Siebel Clinical setup and support
of all clinical trials in North and South
America. Ensured proper communication and
participation in design, training, validation,
implementation and support of Siebel Clinical.
Developed and executed quality testing scripts
for internally updated releases of Siebel
Clinical. - Large Contract Research Organizations Global
trainer of multiple user levels and roles of
Siebel Clinical and internal business processes.
Involved with creating and updating the global
Siebel Clinical training materials for rollout
company wide. Supported users and business
support team through ongoing training and problem
solving.
Quinn graduated from UNC-Wilmington and
AB-Technical College in 1996.
13Becky ReadConsultant, Trainer
Ms. Read has been with Triumph Consultancy for
over two years as one of their top trainers in
Siebel Clinical. Prior, she was providing
high-level system support to various internal
clients. She has strong technical understanding
of complex systems. Becky lives in the United
Kingdom and works along side the team. She has
been a part of Triumph Consultancy since the
middle of 2007
- Triumph Consultancy Firm Expert trainer in
Siebel Clinical. Assisting in the establishment
of CTMS Support Groups along with management.
Perform knowledge transfer activities with end
users. Develop processes and procedures, write
training materials and deliver in-house training
with administrative and end user staff, sometimes
using eLearning tools. Helped to assess
requirements. - Large Contract Research Organization Acting as
a Business Support Manager. Supervised over
twenty staff personnel to service help desk calls
from internal users of Siebel Clinical. New
releases of Clinical and maintained training
manuals. Prior, she provided support for laptop
and desktop users globally. - Large Contract Research Organization Team
leader in charge of setting up studies in IMPACT
a clinical trial management system. Supporting
project teams during the setup stage and
throughout the project. Assisted with the system
updates. -
- Large Contract Research Organization Promoted
to Technical Leader to manage a call tracking
system. Ensured smooth upgrade by configuring
requirements, assisting with installation and the
final rollout.
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