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Operations director, QA program leader

Location:
Saint Johns, FL
Posted:
December 14, 2021

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Resume:

Laura Lee DeVries, CCRC

Senior Clinical Operations Leader

Jacksonville, FL phone/text: 612-***-****

www.linkedin.com/in/laura-lee-devries

adpnmq@r.postjobfree.com

Accomplished clinical operations director with deep experience in developing biotech research organizations to high value, securely positioned enterprises. Inspires teams to execute strategic vision for Business Plans, Operations, Quality Assurance, and award-winning Business Process Improvement within timelines and budgets while building trust-based relationships with vendors, other CROs, healthcare institutions, biopharma companies and regulatory authorities. Over twenty-five years of Phase 1-4 clinical development per ICH GCP standards leading to the launch of innovative health products like monoclonal antibody therapies, cancer drugs, CAR-T cell therapies, and SARS-Cov-2 treatments and test-kits among other healthcare breakthroughs.

CAREER HIGHLIGHTS

Develop strategy for product development at Blink Science, named to the “50 Smartest Companies of 2021” by the Silicon Review, Aug 2021.

Founding Director of Care Access, of Reify Health, Inc, directing exponential growth of a new DRO from concept to valuation of $2.2 billion WSJ Pro Venture Capital Aug 2021).

Project leader in the COVID-19 Alliance: pioneering work on the ultra-fast 1- month startup of the decentralized clinical development of neutralizing anti-body treatment prospects from Lilly, AstraZeneca and others.

Recipient of the Jacksonville Business Journal Award as the 10th Fastest Growing Private Company in NE Florida, citing 116% revenue growth at East Coast Institute for Research.

Institutional regulatory oversight through Quality Assurance program development at UMN, ECIR, Care Access and Blink Science.

CORE COMPETENCIES

Communication: deep understanding and presentations to convey technical, legal, and medical/scientific concepts to investors, stakeholders, and regulatory authorities.

Results-driven leadership through analytical problem solving and continuous process improvement.

Hundreds of pharmaceutical, biologics and medical device clinical trials completed throughout career.

PROFESSIONAL BACKGROUND

LLD Consulting, LLC, Jacksonville, FL

Founder and Lead Consultant; 05/2021- present

Management, Operations, and Regulatory expertise in developing Research and Biotech companies.

Blink Science Inc., Jacksonville, FL; 05/2021 – 10/2021

Biotech start-up developing revolutionary IVDs paired with health record software.

Project Management Consultant

Define and manage global regulatory strategy including EUA, 510K and EU MDR.

Lead Quality Management activities according to ISO 13485, cGMP, GLP, and GCP standards.

Plan and market global pandemic response ABSL-3 facilities for countries around the world.

Contribute to BARDA and DOD grant proposals to fund future R&D.

Create and implement company-wide training program for ISO 13485, cGMP, EU MDR, design control, R&D phases, QMS and other topics.

Edit business plans, investor presentations and global marketing materials.

Draft clinical development plan, summary of clinical validation protocol and label.

Collaborate with CROs to set up pre-clinical and clinical development services.

Care Access of Reify Health, Inc.; Boston, MA (remote from FL); 09/2016 - 04/2021

Fastest growing Decentralized Clinical Research Organization (CRO).

Founding Director

Leadership, Strategic Planning

Report to the CEO/Founder: setting the course for overall business strategy by fast-tracking, planning, and driving company objectives through period of 1000% growth.

Collaborate with pharmaceutical and medical device companies to conduct hundreds of clinical trials.

Create processes and build teams for multiple departments: Clinical Research, Finance, Contracting, Quality Assurance, Study Activation, Regulatory, and Staff Education.

Consultant to parent company, Reify Health, Inc. on the Study Team™ (SaaS) product.

Author company-wide resources to establish policy, and improve productivity, quality, and efficiency.

Collaborate on marketing presentations to distinguish brand and align with growth goals.

Clinical Operations

Direct cross functional teams of project managers, clinical research managers, regulatory managers, contract and budget specialists through deliverables clinical trials.

A leader in establishing innovative CRO services: Sites on Demand, Decentralized Clinical Trials, and Mobile Clinical Trial programs.

Establish and manage a nation-wide network of vendors to supply clinical trial services.

Hire, lead, train, and motivate other staff/managers within the organization.

Provide input into protocol development and project planning for sponsor clients.

Deliver timely clinical project activations including contracting, site set up, vendor management, regulatory management, and quality source document creation.

Project leader in the Covid-19 alliance for the ultra-fast launch of treatments, preventatives and home-test kits for Lilly, AstraZeneca, and other sponsors.

Manage all subject injuries in compliance with pharmacovigilance requirements and best practice standards.

Regulatory Affairs and Quality Assurance

Design and implement the Research Quality Assurance program including the audit process, corrective and preventative action program and institutional training programs.

Direct oversight of regulatory affairs, regulatory management, and IRB relationships.

Author and implement resources to improve research conduct standards: e.g., SOPs, and guides like the FDA Inspection Preparation, Site Activation Guide and others.

Develop and present institutional practices and training for all staff and investigators including trainings on CRC conduct, HRPP, HIPAA, FDA, BBP and others.

Manage all aspects of sponsor, and FDA audits and communications with FDA.

Conduct ICH GCP clinical site inspections and write/implement/review Corrective Action Process Improvement plans, then turn results into institutional improvements.

Institutional Official for the Federal Wide Assurance.

Develop and lead the Human Research Participant Protection program.

Financial and Administrative Operations

Create, and oversee processes for financial management and business operations to meet growth objectives.

Hire, train/develop and lead Financial Assistants through financial operations.

Integrate the processes for financial and clinical teams leading to dramatic EBITDA increase.

Create and implement the research billing compliance program to support compliance with Medicare regulations, the Sunshine Act, and anti-fraud and anti-kickback statutes.

Contracting and Budgeting Oversight

Head of Contracts: fast, accurate legal drafting and negotiation of hundreds of contracts: CTAs, MSAs, BAAs, CDAs, consulting agreements and other contracts as institutional signatory

Head of Budgeting: create, negotiate, and manage hundreds of millions of dollars’ worth of budgets.

Responsible for all vendor contracting and management.

East Coast Institute for Research, LLC; Jacksonville, Florida; 02/ 2012 - 08/2016

Clinical research organization for a regional collection of clinics and hospitals.

Director

Clinical and Business Operations

Report to President/Founders while leading widespread operations improvements for a company that conducts IND, IDE and other clinical trials at private practices and hospitals on behalf of pharmaceutical, medical device and biotechnology companies.

Implement Clinical Trial Management (CTMS) software (Clinical Conductor) across network to support financial cycle reporting, management of clinical trials, and tracking staff performance metrics.

Co-author board meeting presentations, BD presentation, company newsletters and company brochure.

Ascension Health hospital governance council member and IRB liaison for AH, Baptist Medical Center, Memorial Hospital, and other institutions.

Create company policies, presidential correspondence, articles, presentations, performance reports, employee onboarding, training, and HR programs.

Quality Assurance

Set up and lead clinical research quality assurance program including research site audits, CAPAs and other organizational quality system improvements.

Write/edit all clinical SOPs for use at all research sites.

Conduct compliance inspections and manage serious research compliance issues for FDA regulated trials.

Design and implement the research billing compliance program for hospitals and clinics.

Finance and Administration

Lead overhaul of finance department, creating reliable standard process and workflows for all operations resulting in 500% increase in invoices and 116% Net Revenue growth.

Build a financial team and lead them through all aspects of F&A operations including, P&L, EBITDA calculation, AP, AR, tax prep, payroll, quarterly/annual forecasting and reporting.

Oversee and create HR policies, benefits programs and employee onboarding.

Re-design administrative/financial infrastructure to improve revenue capture, EBITDA, risk management, information technology (IT) support, and business metrics reporting.

Contracts and Budgets

Develop contract and budget department and lead all contracting and budget creation with pharmaceutical and medical device companies, hospitals, clinics, physicians, vendors, and other service providers.

Medtronic; Fridley, Minnesota; 05/2011 - 01/2012

World’s largest medical device company.

Clinical Research Specialist

Author reports for submission to FDA to support regulatory requirements for medical devices.

Prepare and negotiate clinical trial agreements, consulting agreements and budgets.

Coordinate with cross functional teams of matrix environment to achieve initiation goals of global clinical trials.

University of Minnesota & University of Minnesota Medical Center – Fairview; Twin Cities

Best Global Universities Rankings: Top 50 schools of 2020.

Research Compliance Auditor for the Office of Regulatory Affairs; 09/2009 - 09/2010

Provide institution oversight of all human subjects’ research through compliance audits across five campuses, the IRB, the hospital, and other partnerships.

Enforce compliance with federal regulations including FDA, HHS, ICH/GCP, ISO and HIPAA, as well as the policies of the UMN and Fairview Health Services.

Assist investigators with INDs, IDEs, HDEs, tissue and data repositories, biosafety facilities, animal use, controlled substance use and embryonic stem cell research.

Create reports and risk assessment presentations for UMN VP of Research, department heads, IRB, hospital administration, legal counsel, and other internal stakeholders.

Contribute to real world outcome database of all organ transplant recipients and donors.

UMN Department of Surgery, Organ Transplant Division

Clinical Research Project Manager; 05/2005 - 09/2009

Manage all industry-sponsored IND, clinical trials for organ transplant including regulatory, study conduct, contracting, and financial administration.

Ensure medical device and pharmaceutical trial conduct is in accord with all sponsor requirements, FDA regulations, University policies, and GCP guidelines.

Top enroller leading to FDA approvals of Belatacept (one of the year’s “10 Most Promising New Drugs”, Bloomberg BusinessWeek).

UMN Blood and Marrow Transplant Program, in partnership with the Masonic Cancer Center Clinical Program Coordinator, Team Leader; 02/1995 - 02/2005

Lead biostatistical data management team of a large-scale Oracle clinical outcome database for all stem cell therapies and global research registry affiliates.

Research therapies for oncology, metabolic, hematologic, and immune deficiencies while investigating ways to minimize GVHD, infections and other sequela of transplant.

Develop and implement new data management policies, OPs, and training resources.

Collaborate with international transplant registries: NMDP, IBMTR, Red Cross and others on early and late-stage biologic therapy protocols.

Acknowledged by heads of adult and pediatric BMT for contributions to achieving the first international program accreditation.

Continuous Process Improvement Award winner for high quality data.

OTHER PROFESSIONAL EXPERIENCE

Assistant Scientist at UMN, NDSU & ISU: conducting advanced lab research including gene transfer, PCR, animal neurophysiological studies, electro-chemistry, HPLC, and other advanced techniques.

Clinical Research Associate (2 yrs.) for large real world evidence Cardiology projects at the UMN School of Public Health.

3M, Technical Scientist (2 yrs.) Corporate R&D to develop a genetic test kit for a Fortune 100 company.

EDUCATION

University of St. Thomas School of Business, Minneapolis, Minnesota

Mini Master’s in Project Management

University of Minnesota, Academic Health Center Minneapolis, Minnesota

Education and Training Program for Clinical Research Coordinators Certificate

University of Minnesota, College of Biological Science,

Bachelor of Science in Biochemistry with completed second major in Psychology

CERTIFICATIONS and AWARDS

Association of Clinical Research Professionals Certified CCRC

P.A. Auszer and William H. Bell Awards in Chemistry

Published on National Dean’s List honoring America’s outstanding college students

THERAPEUTIC AREAS OF RESEARCH

Cardiology

Dermatology

Diabetes

Endocrinology

Epidemiology

Gastroenterology

Genetics

Hematology

Immunology

Infectious Disease

Internal Medicine

Interventional Cardiology

In Vitro Diagnostics

Medical Device

Metabolic Diseases

Nephrology

Neurology

Oncology

Ophthalmology

Pediatrics

Psychiatry

Pulmonology

Rheumatology

Solid Organ Transplant

Surgery

Stem Cell Transplant

TOP PROFESSIONAL SKILLS EMPLOYED OVER 10+ YEARS

Analytical Decisions

Budgets

Clinical Operations

Clinical Trials

Collaborations

Communication

Change Management

CRO Management

Entrepreneurship

FDA

ICH GCP

Influence/Negotiation

Scientific Writing

Legal Drafting

Medical Device Industry

Patient Safety

Pharmaceutical Industry

Presentations

Problem Solving

Process Development

Project Management

Quality Assurance

Regulatory Compliance

Research

Risk Management

SOPs

Strategic Agility

Team Building/Mentoring

Training



Contact this candidate