Sales Manager

Location:

Menifee, CA

Posted:

September 06, 2013

Contact this candidate

Resume:

Wendy Plasko, BS, CCRC

Home: 561-***-**** / Work: 919-***-****

Location: Inland Empire / southern California

Personal e-mail: *********@*****.***

EXPERTISE

. 11 years direct participation in clinical research studies, in both

pharmaceutical and device trials

. Provider Relations Manager of network of 400+ research physicians

. Resource for clinical trial start up, trial procedures, and

complicated malpractice issues

. Directed site start-up including 1572s, CRFs, eCRFs, and IRB contact

for Phases II-IV

. Devised patient identification plans; personally handled consent,

procedures, medications and close-out

. 17 years of experience as an Executive managing a very successful

specialty medical practice

. 14 years of experience as an Executive managing an ancillary medical

business

. Proficiency managing and supervising employees, contracts, HIPAA

compliance, finances (A/R, A/P)

. Continuously developed and improved SOPs; recommended efficient

utilization of available resources

. Internal quality control including review assessment and compilation

of proactive QI policies

. Compiled, organized, and created accessibility to corporate

information for internal stakeholders

. Responsible for skillful, accurate, and extensive metrics compilation

. Successful small business owner and internet business owner, including

B2B sales

PERSONAL QUALITIES CRITICAL TO ENSURING BUSINESS ACCOMPLISHMENTS

. Meticulous eye for details and accuracy

. Ability to correctly and efficiently prioritize work responsibilities

. Superior and clear verbal communication, writing and editing skills,

and group presentations

. Ease in managing teams, and in eliciting maximum performance from

those supervised

. Understanding of the motivation for, and necessity of, pride in work

ownership

. Openness to parallel approaches to business challenges

. Business style incorporating accountability to all levels on the

corporate flow chart

. Respect for evolving understanding of co-workers' abilities and

talents

. Descriptors: flexible, creative, personable, energetic, well-

organized, knowledgeable

. Belief in the pragmatic approach: Identifying the Task, Planning for

It, and Getting It Done!

EMPLOYMENT EXPERIENCE

04/13 - present CEO, Principal and CoFounder, Trial Concierge,

LLC (based in Raleigh, NC)

06/10-03/13 Principal and CoFounder - Trial Concierge, LLC (based in

Raleigh, NC)

. Full Trial Management Company, including new business

opportunities, study start-up, organization, regulatory

submission, and metric review

Accomplishments:

. Devised a business plan with specific milestone goals,

including pro-forma projections, most of which have been

exceeded

. Created two business contracts from scratch to implement

business goals, then consulted with a healthcare

attorney to provide approval for the final versions

. Built a national clinical research network from the

ground up encompassing sites from coast to coast;

currently contracted with sites totaling 125% of our

site goals, over 100 PIs at 50 separate sites in single

practitioner offices, group practices, and hospital

networks with multiple site locations

. Tailor opportunities on the basis of matching individual

PI specialties and experience with appropriate trials in

order to minimize wasting time both for the sites and

for the CROs and pharma looking for specific site

features

. Partner with other research networks and establish

strategic alliances with key industry stakeholders,

including CROs

. Continually mentor sites by consultation and provide

almost 24/7 access; successful enrichment of both

research-experienced AND na ve sites through parallel,

site-appropriate business models

. Continually bring research opportunities, A/R and

operational support, regulatory document expertise,

subject recruitment planning, and additional revenue

streams to our sites

. Bring continued relevant resources to sites in the form

of free continuing education opportunities for PIs and

their support staff, free IATA training information,

clinical trial management software options, and online

and in-person industry training opportunities, along

with reinforcement of final site responsibilities as

individual trials close

04/07-05/09 Last title: Quality Improvement Manager/Internal

Auditor

Previous titles: Provider Relations Manager and Clinical

Database Administrator

eCast Corporation (Raleigh, NC)

Responsibilities:

. Internal Auditor of clinical trials procedures,

processes, finances and data

. Half of advance team assessing viability of managed

research opportunities

. Central contact/team member credentialing and training

physicians for clinical trials

. Designed computer search formulas to identify patients

for clinical trials

. Created, assembled, organized, prioritized and quality-

checked spreadsheets, SOPs, correspondence, and

proficiency testing

. Submitted regulatory documents with technical expertise

. Advocated for physician interests in contract matters

. Devised, collected and analyzed trial demographic and

financial metrics

. Implemented and continually refined the national CRC

Training Program

. Sales experience: Accompanied the Director of Business

Development on sales calls to CROs and pharma for in-

depth explanation of our model

. Backup CRC for primary CRCs

Accomplishments: Awarded ACRP's CCRC certification in

March of 2008 (currently re-certified through May of 2014)

2006 - 2007 Clinical Research Coordinator - Boston MedTech Advisors

(NC locations)

. Primary responsibility for implementing all study-

related goals and protocol parameters for a Boston-based

company's second clinical trial site at Duke University

Medical Center in Durham, North Carolina

. Cooperated closely with the hospital's clinical trial

staff, and set up and monitored patients (both in the

hospital and in their homes around the state) in

preparation for and during trial implementation, always

utilizing HIPAA-compliant methodology; closed out study

in patients' homes

. Installed computers and medical devices, routers,

wireless adapters, and set up both wired and wireless

internet capability in patient homes

. Supervised an assistant, and arranged extraordinary

trial needs with an independent IT company which

provided trial support on a PRN basis

. Partially responsible for ensuring CRF completion,

transmitted both monitoring and hospital data by e-mail

and Excel, and reported timely trial status to the

hospital and the employer

. Performed home compliance monitoring visits and on-line

patient video monitoring in real-time

. Maintained and organized secure storage and inventory of

all trial computers and medical device and peripherals;

ensured and verified appropriate device choices for

various treatment arms of the study

. Hosted visits from the trial device manufacturer's CEO

and his assistant on their fact-findings trips from

Japan to the USA

. Treatment modality: device to combat fatigue in

Hepatitis C patients

1997-2004 Clinical Research Coordinator - Diabetes and Endocrinology

Treatment Center of the Palm Beaches (Palm Beach Gardens,

FL)

. Performed Informed Consent of patients, dispensed and

monitored investigational product; attended start-up

meetings, filed all Case Report Forms on paper or

through the use of EDC (electronic data capture);

reviewed and negotiated study budgets; signed CDAs;

submitted applications and periodic updates to

appropriate Institutional Review Boards

. Therapeutic areas included diabetes, osteoporosis, human

growth hormone, and bladder control, among others

1987-2005 Practice Administrator and Executive - Diabetes and

Endocrinology Treatment Center of the Palm Beaches (Palm

Beach Gardens, FL)

. Administration of all practice responsibilities

including hiring and supervision of eight employees,

medical assisting with in-office procedures, setting of

fees, managing accounts receivable and payable, handling

all contract evaluation and negotiation, payroll,

compliance with all applicable regulations such as HIPAA

(including serving as HIPAA compliance officer), medical

waste management, medical malpractice, implementation of

practice fiduciary goals, evaluation of efficiency and

management practices including managed care

relationships, patient termination, insurance questions

and problems, and applicable federal and state tax

filings

. Sales experience: witnessed and evaluated first-hand

how pharmaceutical representatives and other salespeople

approached our office in an effort to enhance the appeal

of their products and services; attended to the

persistent need to implement malleable strategies to

attract new patients to both the clinical and the

research component of the practice amidst a constantly

changing remuneration landscape

1987-2007 Founder and CEO - Top of the Line Computers, Inc. (FL-

based corporation)

. Chief executive responsible for all business decisions

. Designed and wrote content of subsidiary websites

. Arranged all advertising sales

. Sales experience included devising contracts, linking to

shopping carts, collecting metrics, web design edits

utilizing Dreamweaver software

. Assessed client satisfaction

1983-1985 Legal Assistant - Molloy, Jones, Donahue law firm and E. C.

Garcia and Company, Inc. Real Estate Development Company

(Tucson, AZ)

. Served as the contract proofreader for legal content,

consistency, and grammar; chosen to polish all documents

before public dissemination; invited to recommend

rewrites to improve document impact; employed by an

Attorney/Tax Accountant

1981-2004 Medical Transcriptionist (Ann Arbor, MI; Ypsilanti, MI; St.

Petersburg, FL; and Palm Beach Gardens, FL)

. Transcribed medical records of endocrinology and most

other specialties; employed by hospitals, medical

offices, and private companies

EDUCATION Bachelor of Science in Biological Anthropology and Zoology

(interdisciplinary) from the University of Michigan - Ann

Arbor; admission to the Honors Program (without

application) based on high SATs and standing as Class

Salutatorian; graduate classes at the University of Arizona

in Tucson

TECHNOLOGY Adept with computers and Internet use; highly proficient in

written and oral communication, including composing letters

and creating presentations; use Microsoft Windows XP,

Microsoft Windows Vista, Microsoft Office 2007 (and

earlier), QuickBooks, e-mail, word processing, sales tools,

and spreadsheet software daily: Outlook, MSWord, Excel

MEMBERSHIP Member of ACRP since March of 2008; CCRC certification in

March of 2008 and recertification in May of 2010 (currently

certified until May of 2014)

HOBBIES Tutor high school students in introductory and advanced

algebra, geometry, and math, and edit their writing to

improve communication skills and testing scores; SAT and

ACT tutor; enjoy writing, playing piano, painting, and

traveling

REFERENCES

Any or all of the following professional and personal references available

upon request:

1. Director of Business Development for Clinical Research (current and

previous co-worker)

2. Director of Clinical Services (direct manager at previous employer)

3. Site Directors (multiple) at current national research network sites

4. Internal CRO employee

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Wendy Sheila Plasko, BS, CCRC

Ann Arbor, MI 48104

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Certification: CCRC

Initial Certification Date: 03/08/2008 ACRP Membership