David M.
Clinical Development and Operations Leader
- Role
- Director Clinical Operations at Aligos Therapeutics
- Location
- San Juan Capistrano, CA, US
- LinkedIn followers
- 500 followers
About David M.
Sr. Level Clinical Operations Management Leader with extensive experience in Pharmaceutical & Medical Device Phases I-IV clinical trial and program management. Extensive knowledge of clinical development processes and regulations governing clinical research activities including GCP standards, ICH guidelines, and ISO requirements. Process and compliance driven, committed to the highest standards of quality for conduct of clinical research and development activities
Experience
Director Clinical Operations
Aug 2025 — Present · San Francisco, CA, US
Identification of program risks and development and implementation of mitigation strategies. Set up of (e)TMF, ongoing quality review and final reconciliation of study documents. Ensuring GCP compliance and inspection readiness are maintained throughout study conduct. Performing Sponsor quality oversight of clinical investigational staff and SPs. Contribution to the development of clinical trial management best practice processes and SOPs and to department initiatives to improve the efficiency and effectiveness of the Clinical Operations group
Education
Walden University
MS, Psychology
2004 — 2008
UC Santa Barbara
Bachelor of Arts (B.A.), English Literature
1990 — 1995
Skills
- Nda
- Clinical Trials
- Ich-Gcp
- Infectious Diseases
- Pharmaceutical Industry
- Sop
- Fda
- Gcps
- Pharmacovigilance
- Medical Affairs
- Ind
- CRO
- Pharmaceutics
- Oncology
- Protocol
- Clinical Monitoring
- Clinical Study Design
- Drug Development
- Gcp
- Corporate Integrity Agreements
- Neurology
- Integrity
- 21 Cfr
- Ich Guidelines
- Biotechnology
- Regulatory Submissions
- Ophthalmology
- Clinical Development
- Clinical Operations
- 21 Cfr Part 11
- Clinical Site Monitoring
- Medical Writing
- Data Management
- Clinical Data Management
- Clinical Research
- Oracle Clinical
- Dermatology
- Ide
- Regulatory Affairs
- Edc
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