Barrie Harper

About Barrie Harper

Senior-Level Operations Leader with extensive experience in cross-functional drug development to combat infectious diseases (HIV, hepatitis) and in clinical laboratory settings. Facilitate cross-functional teams to develop and coordinate research and administrative activities of multiple clinical research trials to meet drug development project goals. Establish step-by-step plans for pharmaceutical research candidate identification through post-marketing approvals and life-cycle marketing management. Review and enhance methodologies and ensure projects are completed within established schedules, while coordinating resources. Associate member, American Society of Clinical Pathologists (ASCP). Recipient of “Value At Work Award” in 2004 in recognition of contributions to project teams.Specialties: Drug Rsch & Dvlt;Team Collaboration; Project Leader Mentorship; PDM Tech Transfer; In-licensing; Inter-company Alliance Mgmt; INDs, SPAs, sNDA, sMAA, FDA PMCs, EU CFUMs, PSURs, protocols, reports; Recognized for diplomacy, tact & achieving milestones in matrix organizations; Product Lifecycle Mgmt; Forecast budgets, revenue & ROI; Lab QA & Improvement; CAP / CLIA Lab Inspector; Audited lab data; Senior mgmt presentations, dvlt plans, timelines, visios, budgets, investor relations updates

Experience

1. Senior Project Leader

   Duke Clinical Research Institute

   Dec 2010 — Present · Raleigh-Durham, NC, US

   Clinical Trials Project Leader Jul 2017 - presentClinical Trials Project Leader II Jan 2014 – Jun 2017Clinical Trials Project Leader I Dec 2010 – Jan 2014•Lead (Nov 2022 - present) workstreams of the https://recovercovid.org/ Data Coordinating Center housed at DCRI including but not limited to: IRB submissions, data security reviews, site contracting, leading knowledge management (document storage and metrics). Coach, train and mentor RECOVER Project Leaders.•Galvanized and developed a COVID-19 Testing Core of scientific, physician, NIH and procurement experts to ensure the proper deployment of FDA authorized COVID-19 testing strategies in underserved communities from October 2020 – November 2022.(https://radx-up.org/research/covid-19-testing-tips/). Trained and mentored the Testing Core’s associate project leader.•Honed operational leadership of ARLG Laboratory Center from March 2019 – October 2020.•Led Clinical Operations for multiple government funded trials totaling >$20M enrolling ~4,500 participants. Led virtual teams across 3 companies, NICHD and ~50 (US and global) research sites for the Pediatric Trials Network (PTN) https://pediatrictrials.org/. Led protocol development to execute novel, complex pharmacokinetic PTN clinical trial to study >70 molecules. Partnered with business development to create industry and government study proposals to win new business ($5.2M contract won) for DCRI. Partnered with physicians to develop protocols. Partnered with Regulatory to submit and maintain multiple INDs. Conducted risk analyses. Supervised direct report 01/2012 – 05/2013. Oversaw analytical lab testing for the PTN and expanded from one lab to four. Mentored new Project Leaders. Selected to conduct interviews DCRI Director candidates. Facilitated PTN Executive Committee meetings and monthly pharmacology meetings. Awarded Star Performer in recognition for motivating teams, operational excellence and fiscal management.

Education

• University of North Carolina at Greensboro

  BSMT cum laude, Medical Technology

  1990 — 1991

• University of North Carolina at Greensboro

  BA, Biology / Chemistry

  1986 — 1990

Skills

• Ind
• Glp
• CRO
• Infectious Diseases
• Oncology
• Protocol
• Regulatory Affairs
• Cross-Functional Team Leadership
• Product Lifecycle Management
• Clinical Development
• Timelines
• Biotechnology
• Clinical Trials
• Budgets
• Clinical Research
• Clinical Pharmacology
• Pharmaceutical Industry
• Fda
• Quality Assurance
• Regulatory Submissions
• Cap
• Edc
• Pharmacology
• Ctms
• Drug Development
• Gcp