Heather Marino
Digital Transformation and Clinical Innovation SME | Clinical Operations | Clinical Development Technologies (EHR2EDC, Trial Optimization, Site Selection, Patient Identification) | eSource Subject Matter Expert
- Role
- Senior Director, Digital Transformation and Clinical Innovation at Axtria - Ingenious Insights
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Heather Marino
Experienced, highly motivated clinical research and operations professional with a multi-disciplinary approach that brings together all health research business segments to address critical questions and challenges. Focused on offering better, data-driven insights and innovative operations, product development and program management skills to support the advancement of science and improve global health care delivery. Significant experience in provider site and CRO clinical operations and project delivery, project/program management, product development, RWD/RWE, line management, investigator-initiated research, grant writing, protocol development, study coordination, data management, lab management and business development. Has served as project leader, focusing on mentorship and development of reporting staff. Well versed with site feasibility and initiation, study operations and resourcing, audit preparation, budget/contract negotiations, study metrics tracking, development of study SOPs and MOPs, IRB management and correspondence, EDC, and ICH/GCP. Areas of expertise include business operations, patient-centric trial design, patient recruitment, patient engagement and retention, patient advocacy, digital and decentralized trials, bioethics, genetic research, blood and tissue repositories, the return of actionable and incidental findings to research participants, lay summaries, clinical trials data sharing and transparency, informed consent, surrogate decision-making and end of life care. Therapeutic background includes oncology, immuno-oncology, hematology, psychiatry, neurology, cardiology, vascular and cerebrovascular medicine, stroke, genetics, genomics, and biobanking.
Experience
Senior Director, Digital Transformation and Clinical Innovation
Jul 2024 — Present · Pittsburgh, PA, US
Education
University of Pittsburgh
Bachelor of Arts (BA)
Boston University
Master of Liberal Arts (MLA)
University of Pittsburgh
Master of Arts (MA)
Skills
- Editing
- Microsoft Word
- 21 Cfr Part 11
- Human Genetics
- Program Evaluation
- Qualitative Research
- Fundraising
- Data Analysis
- Financial Management
- Business Strategy
- Powerpoint
- Microsoft Excel
- Project Management
- Entrepreneurship
- Biobanking
- Bioethics
- Research Design and Development
- Web Design
- Microsoft Office
- Sales
- Healthcare
- Clinical Trials
- Business Innovation
- Politics
- Angularjs
- Ctms
- Event Management
- Cascading Style Sheets (Css)
- Strategic Leadership
- New Business Development
- Leadership Development
- Css
- French
- Higher Education
- Clinical Data Management
- Public Speaking
- Clinical Research
- Leadership
- Javascript
- Node.js
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