Marie Simerly
Dynamic Proj Delivery Leader | Strategic Partnerships | Change Champion
- Role
- Director of Scientific Project Management at Altasciences
- Location
- Lincoln, NE, US
- LinkedIn followers
- 500 followers
About Marie Simerly
My personal mission is to drive positive change, build trust, and deliver excellence in early phase clinical research. With over 28 years of experience in Early Phase clinical research, I currently am the Director of Scientific Project Management at Altasciences. I hold a Project Management Professional (PMP) certification and a Lean Six Sigma green belt certification, and I have successfully directed multiple global Phase I-IIa programs across various therapeutic areas for pharma, biotech, and tobacco clients.Relationships are my passion, so I thrive in strategic partnerships, process optimization, risk mitigation, and team leadership. I have developed and implemented governance models, KPIs, and metrics for top revenue-generating strategic clients. I have extensive experience managing SAD, MAD, renal & hepatic impairment, human abuse liability and tobacco usage & cessation studies, as well as multi-site patient studies in the US, Canada, Eastern Europe, UK, and Australia. I enjoy the change management piece of enterprise resource planning and have successfully worked on multiple project implementations in the past 10 years. Coaching and mentoring are also some of my favorite ways to mold a team, whether directly or indirectly.
Experience
Director of Scientific Project Management
Jan 2025 — Present
Education
Briar Cliff University
BS, Biology and Chemistry
1994 — 1998
Briar Cliff University
Bachelor of Science - BS, Biology & Chemistry, Minors in English & Spanish
Skills
- Drug Development
- Gcp
- Risk Management
- Clinical Trials
- Clinical Development
- Biotechnology
- Management
- Team Building
- Edc
- Contract Negotiation
- Pmp
- Leadership
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Kpi Implementation
- Outsourcing
- Clinical Research
- Capa
- CRO
- Metrics
- Gmp
- Life Sciences
- Program Management
- Crm
- Project Management
- Oncology
- Protocol
- Process Optimization
- Strategy
- Ich-Gcp
- Six Sigma
- Phase I
- Process Improvement
- Clinical Monitoring
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