ROBIN NEWMAN
MSN, CPNP, CCRA, RAC
680 Webb Road 484/574-8444
Chadds Ford, PA 19317
VP/ Executive Director Clinical Operations, RA/QA or Pharmacovigilance
PROFILE
High-caliber leadership experience as a change agent, reliable administrator,
project leader, and corporate entrepreneur in diverse clinical research and
therapeutic applications and environments. Demonstrated abilities in business and
organizational development, multidisciplinary and distributed team management,
clinical operations, training and public speaking, quality systems development
and management, adverse event analysis and pharmacovigilance, and improvement of
overall operating efficiencies.
* Proficient as a top multi-project and multi-site manager in de novo start-ups
and established companies alike involving vendor selection and management,
resource allocation, process improvements, executive relationship building and
development of operating policies and procedures.
* Creative design, implementation and execution of successful, high-impact
training and medical/GCP education programs that encompassed mission-critical
regulatory requirements and performance metrics to facilitate clinical research
projects and business growth strategies.
* Expertise in the regulatory strategy planning and negotiation with top
management and key decision-makers; fully familiar with study and personnel
requirements, industry and practice standards and State/Federal laws and
regulations.
* Effective hiring, management and development of top-notch talent at all
levels; motivation of teams to achieve peak performance, maintain top quality
standards and meet aggressive business objectives.
* Accomplished presenter, leading professional trainer and skilled mentor of
clinical research professionals.
* Strong clinical research background in multiple therapeutic specialties; solid
expertise in pharmaceutical, medical device and biologics product development and
launch, as well as medical writing.
* Founder and highly successful leader and manager of three businesses including
a restaurant corporation, a clinical research consulting
* Registered Nurse (Texas and Pennsylvania), Advanced Nurse Practitioner
(Pennsylvania), Certified Pediatric Nurse Practitioner (CPNP - PNCB), Certified
Clinical Research Associate (CCRA - ACRP), Credentialed Clinical Research Trainer
(CCRT - ACRP) and Regulatory Affairs Certified (RAC - RAPS).
AREAS OF EXPERTISE
Strategic Planning — Client Relations — Regulatory Compliance —
Coaching/Mentoring — Vendor Management — Process Improvement — Contract &
Budget Negotiations — Operational Excellence — Performance Metrics — Change
Management — Workforce Planning — Funding Acquisition
EMPLOYMENT & ACCOMPLISHMENTS
InVivo Therapeutics, Cambridge, MA 2008 “ 2009
Senior Director “ Clinical/Regulatory Affairs
Charged with developing all clinical trial and quality systems de novo for this
start-up medical device firm that is designing a biomedical implant for the
treatment of acute complete spinal cord injuries. Serve as primary contact for
the FDA, lead for all clinical operations, as well as development of
pre-clinical/clinical protocols.
* Succeeded in creating a comprehensive set of clinical SOPs, training
materials, risk & safety management program, developing pre-IDE and IDE
submissions, and designing and conducting several pre-clinical primate trials.
MedTrials Inc., Dallas, TX 1993 “ 2008
Co-Founder & Chief Scientific Officer, 2004-2008
Responsible for providing executive management of all senior consulting
projects, team supervision, regulatory compliance and research processes for this
$10 million full-service specialty contract research organization that focused on
medical device and biotech sectors.
* Lead consultant and POC for all new medical technology clients regarding
regulatory strategy, study design, pharmacovigilance, and DSMBs, DMC, and
Clinical Event/Adjudication Committees.
* Negotiated the purchase of a small data management firm and facilitated the
efficient integration of this service line, including facility development, new
software validation, and hiring/deployment of qualified staff.
Executive Vice President, 1997-2004
Functioned as the COO and oversaw the clinical and quality assurance departments
encompassing all procedures, processes, job descriptions and personnel management
functions. Trained and supervised a group of 2 VPs, 3 directors, 2 assistant
directors, 3 QA specialists, 5 senior consultants, 25 CRAs and a budget of $6
million.
* Designed and implemented a clinical position-specific training initiative and
instituted a 360-degree performance review and management program.
* Introduced a contract auditing and DSMB capacities for the company, including
ID and training of senior auditing and pharmacovigilance personnel.
* Rolled out comprehensive clinical research personnel development programs for
2 large hospital systems.
Vice President “ Clinical Services, 1993-1997
Responsible for all aspects of clinical services, including project management,
monitoring, vendor selection and contracting, study budgeting and CRA/research
site training. Built and led a team of 1 director, 2 managers, 2 senior
consultants, 6 junior consultants and 20 CRAs.
* Ensured solid and profitable working relationships with vendors and a diverse
sponsor clientele.
* Promoted to this position after initial hiring as Consultant; played a key
role in company start-up and overall growth, such as the generation of $2.5
million in newly contracted work.
* Developed and instituted the first set of clinical SOPs for this firm, along
with establishing a company-wide Quality System. Worked in-house with two clients
for 2 years as a senior pharmacovigilance specialists including developing AE
summaries and safety sections for CSRs and regulatory submissions.
Clinical Research Consultants of Dallas, 1992-1993
Founder & President
Independent contract monitoring, training, and consulting to the medical device
and pharmaceutical industry.
* Produced $250K in revenue in the first year of operation, doubling this the
following year.
* Developed and marketed a comprehensive set of clinical site productivity tools
that lead to an acquisition of my company less than one year from it 's
founding.
UT Southwestern Medical School, 1991 “ 1993
Senior Research Associate
Responsible for managed of all clinical research initiatives for the department
of pediatric cardiology. Also functioned as a case manager for the pediatric
cardiac transplant program.
* Completed and published three investigator-initiated clinical trials.
* Designed, developed and managed five clinical trials simultaneously, including
protocol writing, CRF design, data collection and analysis and publication
preparation and submission.
* Performed all primary care and comprehensive case management for 5 cardiac
transplant patients.
Thunderbumpers & Rosie 's Diner, 1989-1991
Director of Public Relations and Market Research
Responsible for the development of public relations and media tools leading to
an IPO. Designed and created all logos, menus, furnishings, and related imaging
tools for the company. Conducted market research of related companies in North
Texas to benchmark appropriate price points and marketing strategies.
* Completed the design, build out, and successful operation of 4 Thunderbumpers
restaurants within 18 months leading to the sale of the company to Rosie 's
Diner Corporation.
* Obtained a Master 's Degree and Certification as a Pediatric Nurse
Practitioner, graduating summa cum laude while working 50+ hours per week.
Electronic Data Systems, 1986-1988
Corporate Recruiter and International Proposal Manager
Manager of a college relations team assembled to facilitate an acute need for
engineers in light of the EDS GM merger. Manager of an international proposal
team assembled to acquire jumbo contracts for facilities management data
processing services
* Number one corporate recruiter in the country within 9 months of hire -
effectively recruited over 350 engineers for project "Saturn."
* Successfully coordinated a multi-national proposal that lead to the
acquisition of a $400 million contract
Baylor University Hospital, 1981 “ 1986
Operating Room Nurse Specialist II
Scrub and circulate across all OR specialties
* Finished 1st in my intern class and promoted to Specialist II during the first
year.
* Was hand selected by the cardiovascular team as a cardiac transplant
specialist.
RELATED EXPERIENCE
* Held various clinical research, nursing, project management and PR positions
with different healthcare, business and consumer-focused companies in Texas.
* Gained senior consulting skills in regulatory strategy, clinical trial
design/execution, SOP development and oversight of various data safety,
monitoring and clinical event adjudication committees.
* Instructed classes as Adjunct Faculty at the Graduate School of Biomedical
Sciences at the University North Texas Health Science Center, as well as the
University of Texas Southwestern Medical Center.
* Member of the Board of Trustees for the Association of Clinical Research
Professionals; served as Finance Chair, Vice Chair, Chairman and Immediate Past
Chair.
* Recognized with numerous professional and academic awards, such as Most
Outstanding PNP Student Award , UT-Arlington, Distinguished Alumni Award
in 2005 from School of Nursing, UT-Arlington, Phi Kappa Phi National Honor
Society, Sigma Theta Tau National Nursing Honor Society and others.
EDUCATION
George Washington University, Washington, DC
Currently finishing a Doctorate in Education “ Executive Leadership Program.
GPA 4.0/4.0
University of Texas, Arlington, TX
M.S. Degree in Nursing; Pediatric Nurse Practitioner; PNP Certification GPA
3.9/4.0
University of Dallas, Dallas, TX
Completed coursework to |
