1. Karen Nowatkoski
108 E Seve Court, Morrisville, NC 27650
knowatkoski@yahoo.com
919-219-5456
SUMMARY OF EXPERIENCE:
Twenty - seven years ofglobal clinical research experience,including executivelevel responsibility for the
successful and collaborativeleadership ofclinical operations management, site management, clinical monitoring
teams, process/system developmentand implementation,global project management and project delivery,
business development and pricing support. Responsible for staff resourcing and recruitment for critical
positions.
PROFESSIONAL EXPERIENCE:
Senior Director, Clinical Operations Leads, Americas, PAREXEL International, Durham, NC
October 2015 to present
 Support and direct the Americas Clinical Operations Leads (approx. 255 FTEs).
 Develop plans to improve the clinical delivery across projects, programs, and portfolio’s for our
clients/partners
 Provide support ofregional and functional strategic initiatives and collaborate with seniormanagement
across disciplines to develop implementation plans.
 Responsible for hiring targets, processes and on boarding including training standards for the global clinical
operations lead team.
 Support Customer face to face meetings globally, including new business opportunities, joint operations
committees.
Senior Director, Site Alliances,Americas, PAREXEL International, Durham, NC
August 2013-October 2015
 Support and direct the Americas Site Alliance Strategy.
 Develop plans to improve patient enrolmentto meet customer expectations through the Alliance Site
Program.
 Determine strategic goals for AllianceSites within the Americas.
 Provide support ofregional and functional strategic initiatives and collaborate with seniormanagement
across disciplines to develop implementation plans.
 Collaboratewith Clinical Operations and provide opportunities in the regions for Relationship Manager
support.
 Responsible for hiring targets, processes and on boarding including training standards for the division.
 Support Customer face to face meetings globally.
Director, Clinical Operations, Head ofOperational Delivery,Clinical Operations and Transformation, Cognizant
Technology, Teaneck, NJ
October 2011-August 2013
 Responsible for Operational Delivery for the Clinical Transformation softwaresolution, which
Included the implementation ofa system designed to enable and support on-going clinical risk assessment,
application oftrial monitoring strategies, configurable workflows and other clinical trial management
activities.

2. Karen Nowatkoski
108 E Seve Court, Morrisville, NC 27650
knowatkoski@yahoo.com
919-219-5456
 Supported the development and implementation ofRisk Based Monitoring scoring methodology and process
to help enable sponsors and CROs to initiate Risk Based Monitoring strategies.
 Provided consulting services to Pharmaceutical Sponsors and CROs for the development and
implementation ofRisk Based Monitoring strategies and methodologies,as well as related operational
solutions.
 DevelopedStandard Operating Procedures (SOPs) and training collateral for operational processes and
technology use globally.
Senior Director, Integrated Site Services, Quintiles, Inc
June 2008-August 2011
 Supported and directed the North America Partner Site Operations.
 Developed plans to improve patient enrolment and meet customer expectations through the Partner Site
Program.
 Ownership of regional and functional strategic initiatives and collaborated with senior management across
disciplines to develop implementation plans.
 Responsible for hiring targets, processes and on boarding including training standards for the division.
 Support Customer face to face meetings globally.
 Liaison with Quintiles Functional Resourcing Group to provide strategy for implementation ofStart - up and
Regulatory Support.
Director/Senior Director, North America Clinical Operations, Quintiles, Inc
August 2002 –May 2008
 Developed and conducted initial pilot for the entry level Clinical Research Associate program (ACE). This
strategic priority was implemented to allow Quintiles to fully staff and deliver on monitoring backlog and
generate the associated revenue. As a result,monitoring revenue targets in North America were exceeded.
 Directed clinical monitoring operations for Quintiles for the largest clinical region including oversight of
operations and development of policies, procedures and standards for clinical trials for approximately 300
staff.
 Responsible for maintaining project realization and revenue generated by the southeast region for clinical
operations.
 Ensured projects were resourced appropriately and employees were trained and developed to meet project
needs.
 Responsible for planning and scheduling workload for staff and ensured adequate levels of training were
carried out to meet performance and quality standards in handling multi-site and multi-project work.
 Assisted in formulating effective strategic goals and objectives for the region. Assured implementation and
operational integration of those goals and objectives as directed by senior management.
 Owner of strategic initiatives that integrated other functional areas of the company which included the
development of new processes and procedures, including measures to evaluate success.
 Regular interaction with customers; including development of monitoring strategies, proposal development,
review of project status, and participation as a member of governance committees.
Associate Director, Clinical Operations, Quintiles, Inc
January 2000- August 2002
 Assisted senior management of clinical department, including resource allocation, strategic planning and
budgeting for profitability.

3. Karen Nowatkoski
108 E Seve Court, Morrisville, NC 27650
knowatkoski@yahoo.com
919-219-5456
 Responsible for recruitment/training of new clinical staff.
 Participated in marketing activities, including capabilities presentations to potential customers.
 Managed and mentored Line Managers, Clinical Team Leaders, CRAs, and Clinical Assistants in day -to day
operations.
EDUCAT ION:
Barton College, Wilson, North Carolina, Bachelor ofArts
Palm Beach Junior College, Nursing Courses
ExecutiveLeadership Courses Completed
LANGUAGE SKILLS:
English:fluent
PROFESSIONAL ASSOCIATIONS:
GreaterGift Initiative- Board ofDirectors: http://www.greatergiftinitiative.org/
Make a Wish Foundation Eastern Carolina Chapter (Volunteer): http://eastnc.wish.org/
Association ofClinical ResearchProfessionals(ACRP)