TEREE OLSON

tereeo1@ix.netcom.com

Plymouth, Minnesota 55446 (612) 819-7727

Highly developed, medically and scientifically trained leader with proven success rates, driven by initiatives,
accomplishments, and impactful results within clinical research, seeks a senior leadership role involving
complex strategies and challenges within innovative research/device trials.
Clinical Trial Research: Strategic Protocol Design, & Development Training Delivery
Project Management US & Global Studies P a t i e n t R e c r u i t m e n t S t r a t e g i e s
G C P F D A Submissions P M A Cardiology CRO Selection Reimbursement Studies
Medical Devices Grant & Contract Management Cross Functional Team Building

EXPERTISE:

SUMMARY:

Project Management Managed large clinical global studies across multiple geographies.
Initiated Class III IDE studies which resulted in FDA approvals. Skilled in CRO selection and
management in Europe and Latin America
Relationship Management Highly experienced in assessing true needs and expectations,
building lasting professional relationships. Grow and deepen strategic partnerships to
achieve mutually beneficial outcome. Recognized for preserving ties to clinical and scientific
leaders strengthening alliances instrumental in achieving company goals.
Leadership Launched well-received project manager program for professional development of
staff. Mentored and coached employees resulting in little to no turnover of team year over year.
Foster team cultures of excellence and maintaining sense of urgency in completing clinical trials.
Motivational leader who energizes teams and inspires cutting edge performance for direct
impact to revenue.

EXPERIENCE:

MDC CLINICAL DEVICE CONSULTING, LLC, Plymouth, Minnesota

2015 to Present
President/Principal Consultant
Administer clinical trial strategy/design for start-up to small companies, specializing in
cardiology; support IDE trials, engaging regulatory and statistical assistance in completion
of submissions to FDA and other regulatory agencies worldwide.
Lead, direct, and drive project teams in planning, execution, and management of all
operational aspects of clinical trial engagements.
Develop and process clinical study budgets US and OUS in the start-up of clinical trials.
Identify and manage subcontracting process for selection of core labs, CROs, advisory
Boards, data management systems.
Create and author clinical documents necessary for project start-up through close-out
enabling Client to start IDE trial within 2 months.
Facilitated approval of an IDE and Post-market Clinical Follow-up Study in Europe.
Executed selection of a Clinical Trial Management System (CTMS) within 2 months

ST. JUDE MEDICAL, Plymouth, Minnesota/US

Director of Clinical Research

2006 to 2015
(2012 to 2015)

Left Atrial Appendage Program

Led global Left Atrial Appendage Closure portfolio of clinical programs, championing global
U.S. and European approvals/launches.
Directed 5 reports plus CRO partners, in 3 successful clinical programs.
Formulated and drove global clinical strategy with Sr. Management/multidisciplinary teams.
Designed programs, wrote protocols, and led FDA interactions producing results to conduct
two global Post-Market studies and two IDE studies.
Championed New Technology Assessment prior to launch completing study within two
months driving team to meet aggressive timelines and obtain CE mark.
Chaired advisory boards, spoke at global conferences, and served as clinical spokesperson
for related medical topics.
Drove publication strategy across studies resulting in presentations and publications in
major medical journals
Built strong relationships with internal business units as well as with external research
collaborators and development partners
Oversaw emergency response team, maintaining training and credentials.

Continued on
Page Two...

Sr. Clinical Programs Manager

(2006 to 2012)
Oversaw three global structural heart programs with a staff of 17 direct reports.
Championed removing barriers to completion in a pivotal study which had been
enrolling over two years.
Engaged a media company, increasing patient screen to enrollment rate by 50%.
Negotiated clinical trial designs and submission responses with FDA in successful
execution of three IDE studies.
Developed numeric site selection process across all trials lessening subjectivity and bias,
providing consistency in physician and site selection
Created and taught clinical project manager course within clinical department, increasing
expertise of clinical managers.
Ensured compliance with GCPs and regulatory guidelines in US and OUS.
Created AOP budget for all clinical programs and ensured monthly accountability.
Selected core labs and vendors as required per the protocol and ensured quality of
services through frequent audits.
Developed a core curriculum for first line project managers with bimonthly classes.

TEREE OLSON
PROFESSIONAL
EXPERIENCE
(Continued):

Page Two

MEDTRONIC CARDIAC SURGERY, Minneapolis, Minnesota

2004 to 2006
Principal Clinical Specialist
Led several cardiac surgery studies, mentoring junior clinical research associates.
Developed/authored two IDE protocols and supplements to FDA in support of a PMA
submission, resulting in approval to initiate studies.
Prepared and authored study related materials (i.e. physician training manuals, patient
manuals, newsletters) increasing enrollment in study.
Coordinated physician advisory board, providing independent review of adverse events
and deaths, improving consistencies in clinical studies across the department.
Developed/executed a pre-clinical animal and cadaver protocol to train investigators
on the procedure to increase expertise.
Determined study objectives, strategy, scope and schedule for cardiac related clinical studies.

RAYMEDICA, INC., Minneapolis, Minnesota

1999 to 2004
Clinical Project Manager
Led, directed, and executed a spinal trial for 5 Canadian sites and 10 European sites
in accordance with strategy, project plans, and approved budget.
Directed physician investigators in the operating room on placement of experimental device,
resulting in fewer complications during the procedure.
Executed all regulatory submissions and correspondence to Health Canada Therapeutic
Directorate Division.
Responsible for the design, implementation and management of Class III IDE clinical projects,
interpretation of clinical results and preparation of study summary reports for presentations,
publications, and regulatory submissions to FDA.

NEUROMOTION, INC. Edmonton, Alberta Canada

1995 to 1999
Director Clinical/Regulatory
Led role in planning, designing and conducting clinical trials across Canada and the US.
Supervised two clinical research associates, and wrote performance reviews.
Responsible for department budget and oversight of expenditures.
Wrote clinical protocols, summaries of S & E and labeling.
Authored regulatory submissions to FDA and Canada.

ENDOVASCULAR TECHNOLOGY, Menlo Park, California

1994 to 1995
Sr. Manager - Clinical
Coordinated and managed two Class III IDE studies for a stent graft for AAA disease.
Responsible for hiring of clinical employees, employee evaluations, dept. budget, and SOPs.
Ensured investigator compliance with applicable regulations, and adequate training and
monitoring were in place at investigative sites.
Collaborated with regulatory staff in providing accurate and timely reports such as annual
reports, safety reports, and study summaries to FDA.

AMERICAN MEDICAL SYSTEMS, Minneapolis, Minnesota

1984 to 1994
Manager - Clinical
Responsible for design, development, management, and coordination of clinical trials.
Developed effective preclinical and clinical strategies and programs to ensure successful
product development and worldwide marketing efforts.
Supervised six clinical research associates, actively involved in clinical site selection,
training, monitoring, and close-out of sites.
Wrote and submitted 510(K)s, IDE submissions to FDA.
Authored clinical protocols, study reports, clinical section in support of PMA submissions.
Collaborated closely with reimbursement in the development of clinical protocols to obtain
third party reimbursement for products.
Managed post-market clinical trial through a large CRO with a $2MM budget.

MEDTRONIC, INC., Minneapolis, Minnesota

1981 to 1984
Cardiac Specialist
Taught and trained cardiothoracic surgeons, cardiologists and electrophysiologists in
the technical aspects of pacemaker functions
Provided real-time monitoring of subject's pacemakers telephonically to all Medtronic
implanted pacemakers; communicated results to subject's physicians.

METHODIST HOSPITAL, Minneapolis, Minnesota

1976 to 1981
Head Nurse Cardiovascular Surgery Unit
Manager of a 33 bed cardiac surgery unit, and $500K budget.
Assisted with the design of a new cardiovascular floor, worked with building contractors in
setting up nurses station and other public areas for patients.
Researched and purchased all needed equipment: defibrillators, telemetry equipment, etc.
Responsible for the hiring and training of all nurses, aides, and unit secretaries.
Formed the first multi-disciplinary cardiac family support group at Methodist Hospital
EDUCATION:

ST. THOMAS UNIVERSITY, St. Paul, Minnesota

UNIVERSITY OF WISCONSIN, Milwaukee, Wisconsin

Mini MBA
BS in Nursing