Director of Clinical Data Technology - Biotech Resume Search
Director of Clinical Data Technology - Biotech Resume Search
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Director of Clinical Data Technology Resume


Desired Industry: Biotech SpiderID: 59588
Desired Job Location: Indianapolis, Indiana Date Posted: 4/17/2012
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 125000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Masters Willing to Relocate: No


Objective:
Intuitive, detail-oriented, and results-
focused professional, with background in
Clinical Trial Operations. Primary
expertise in Clinical Data Management
and associated clinical data
technologies including Electronic Data
Capture (EDC), Interactive Voice/Web
Response (IVR/IWR) and Clinical
Programming. Extensive experience
utilizing project management and
operational skills in delivering high
quality and timely services to varied
biopharmaceutical customer base. Possess
proven record of accomplishment in
managing project teams to successful
project delivery. Demonstrate
proficiency in conducting initial
research, providing data analysis, as
well as evaluating and developing viable
solutions.


Experience:
PROFESSIONAL EXPERIENCE

INC RESEARCH (Kendle International,
Inc.) - Cincinnati, OH
Director, Clinical Data Technology
2009-2012
Director, Biometrics Operations
2008-2009
EDC Training Specialist 2007-
2008
Clinical Data Manager 2006-
2007
Programmer II 2006
Programmer I 2005-2006
Clinical Data Associate II 2005
Clinical Data Associate I 2004-
2005

NORTHERN KENTUCKY UNIVERSITY - Highland
Heights, KY
Research Associate 1998-2004

UNITED PARCEL SERVICE - Cincinnati, OH
Customer Service Associate 1995-
1997

GROSS DIAMOND CENTER - Louisville, KY
Executive Assistant 1987-1995


Education:
EDUCATION

Master of Science in Information Systems
- 2004
NORTHERN KENTUCKY UNIVERSITY - Highland
Heights, KY

Bachelor of Science in Biological
Sciences - 1999
NORTHERN KENTUCKY UNIVERSITY - Highland
Heights, KY
Graduated cum laude - Deanís List and
Scholarís List

Bachelor of Science in Environmental
Sciences - 1999
NORTHERN KENTUCKY UNIVERSITY - Highland
Heights, KY


Affiliations:
PROFESSIONAL AFFILIATIONS

Sigma XI, The Scientific Research
Society - 2001
Beta Beta Beta National Biological Honor
Society - 1998


Skills:
Project/Operations Management
- Administered the execution of
services according to strategic plans
across three distinct technology units
within the Clinical Data Technology
organization, including EDC Technical
Operations, IVR/IWR Operations, and
Clinical Database Programming
- Engaged in comprehensive project
delivery through cooperation and
collaboration with biostatistics,
clinical data management, and
information technology leadership to
ensure global standardization of
services and maintenance of global
standards, policies, and procedures
- Managed and maintained global
customer service project list, including
current and future resourcing
requirements along with systems for
tracking value of new awards and
forecast opportunities for Biometrics
- Made major contributions in
establishing a process for monitoring
the amount, timing, and scope of EDC
training
- Efficiently handled project
timelines, deliverables, financial
results, reporting, and overall quality
- Oversaw all phases of laboratory
operations activities conducted in The
Water Research Laboratory, including
utilization of databases; billing,
budgeting, and purchasing; supervision
of undergraduate student research;
analysis and interpretation of data,
including graphical analysis and
statistics; and preparation of reports
and presentations

Leadership and Development
- Performed well as the global
leader of Clinical Data Technology
services, including database
programming, electronic data capture
(EDC) and IVRS/IWRS activities
- Provided exemplary training;
delegated trainers to projects and
guaranteed all documentation of EDC
training was collected and available
- Closely worked with functional
representatives in the creation of SOP
and Work Instruction training
assessments while also integrating EDC
training courses into an e-learning
system (eKendle College)
- Functioned as the primary Kendle
CDM contact with sponsors and
competently represented CDM on Kendle
project teams
- Executed Biometrics team leader
functions as necessary, ensuring
databases were validated and ready for
transfer and analyses

Communication and Interpersonal
Relations
- Ensured overall consistency and
success through close collaboration with
directors across the organization
- Oversaw and coordinated the
delivery of clinical data technologies
for projects within the area
- Addressed the business needs of
Kendle through submission of accurate,
timely, and consistent clinical data to
both sponsors and other internal
departments

General Administrative Functions
- Applied best management
practices in handling financial
performance and personnel, sales,
marketing strategy, business
partnerships, and overall quality
deliverables
- Administered pricing algorithms,
proposal text, and the overall bidding
process within Biometrics
- Contributed to the formation and
upkeep of project documentation,
including a project for CDMT to collect
documentation electronically (LiveLink,
a document management system) versus
paper (binders)
- Produced ad hoc listings,
reports, and quality control
documentation pivotal in certifying
clinical databases

Sales and Marketing
- Played an instrumental role in
ensuring well-defined and consistent
collection and reporting of metrics for
the Biometrics organization
- Employed best practices in
monitoring global financial and sales
performance across regions, and provided
exemplary assistance to the Vice
President of Global Biometrics in
determining and tracking key metrics
- Rendered exemplary performance
as operational representative on sales
teams as necessary for specific
opportunities
- Frequently participated on the
bid defense teams representing all
aspects of clinical data management and
technology

Technical Proficiency
- Facilitated the data clean-up
process through data archival along with
the approval of building, testing, and
validating clinical databases
- Assumed full responsibility in
managing the maintenance of CDM project
budgets and project plan for assigned
projects
- Served as the scientific
programming representative on Kendle
project teams
- Engaged in the building,
testing, and validation of clinical
databases; receipt and processing of
external data; and programming and
validation of datasets, tables,
listings, and figures according to
sponsor and Kendle requirements and good
programming practices to produce
expected results with minimal errors
- Led the successful completion of
programming activities through
employment of statistical analysis plan
- Demonstrated proficiency in
Microsoft Office (Excel and Word),
Project Plan, Visual Basic, SAS
Programming Language, Relational
Databases, and C++ and Java

Quality Assurance
- Carried out quality control of
programs to ensure that output meets
quality standards and project
requirements
- Assessed and processed clinical
trial data to ensure the accuracy and
consistency of clinical databases
- Accomplished comprehensive
review of case report forms (CRFs) to
ensure the design supports a high-
quality database
- Demonstrated versatility in
executing various data-related
functions, such as CRF tracking, review,
validation, updating, SAE
reconciliation, laboratory data
reconciliation, and safety coding
- Authored and implemented
standard operating procedures
- Employed Integration Testing
database to collect, review and analyze
findings from integration testing of
clinical databases to increase quality


Additional Information:

AWARDS AND HONORS

Faculty-Senate Award - 1999-2000
Greaves Scholarship - 1999-2000
Greaves Undergraduate Summer Fellowship
- 1999
Student Representative Commencement
Speaker - 1999
Outstanding Graduate in Biological
Sciences Award - 1999
First Place, Undergraduate Research
Presentation, The Kentucky Academy of
Science - 1998
Founderís Award from Gross Diamond
Center - 1994



AWARDS AND HONORS

Faculty-Senate Award - 1999-2000
Greaves Scholarship - 1999-2000
Greaves Undergraduate Summer Fellowship
- 1999
Student Representative Commencement
Speaker - 1999
Outstanding Graduate in Biological
Sciences Award - 1999
First Place, Undergraduate Research
Presentation, The Kentucky Academy of
Science - 1998
Founderís Award from Gross Diamond
Center - 1994


CAREER HIGHLIGHTS

- Participated in and directed the
implementation and operation of three
distinct EDC vendor systems within
Global Clinical Data Management and
Technology (CDMT) operations.
Participated in the creation of EDC
specific SOPs and system specific Work
Instructions.
- Adopted innovative ideas in
designing and developing a dashboard for
directors of CDMT to monitor overall
business unit performance, including
metrics on revenue, margin contribution,
utilization, audit findings, and head
count
- Provided outstanding leadership
and guidance to implement a cross
training program across three technology
segments of the Clinical Data Technology
organization in efforts to maximize
billable hours, provide backup resources
and manage peaks and valleys in work
stream
- Ensured effective and efficient
operation, in collaboration with
managers and leadership, by designing
and developing weekly reporting of
global resourcing analysis, RFP flow
analysis, weekly sales, and pending
opportunities
- Played an instrumental role in
implementing many efficiencies that
enabled effective management of CDMT
operations at line management levels and
reducing Director level oversight
- Spearheaded a cross-functional
team, including representation from data
management, database programming,
statistical programming, biostatistics,
clinical project leaders, and clinical
research associates in creating
specifications and templates using CDASH
industry standards for data design and
collection
- Facilitated mentoring and
sharing of responsibilities throughout
the business unit through employment of
subject matter expert (SME) program
- Enhanced efficiency of
departmental selling activities through
development of various materials, such
as a suite of bid defense presentation
decks, tool for estimating project
budgets driven by key assumptions, and
RFI question/answer response database
- Administered the timely
execution of monthly reminder and
recognition program utilizing company
intranet
- Spearheaded the creation of the
CDMT forum which cultivated knowledge
sharing and provided a vehicle for
sharing and celebrating successes
- Improved visibility to
departmental metrics by establishing
Weekly Metric Review Meetings, tracking
tools and brainstorming sessions to
address metric improvements


Reference:
Available upon request.


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