Beth Soffer
Clinical Research & Operations Leader | Project Management Head | Quality & Risk Analytics Group Lead | Sr. Consultant
- Role
- Sr Consultant, Clinical Operations Medical Writing Consulting at Bch Research Solutions, Llc
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Beth Soffer
Experienced Pharma leader with extensive and diverse experience in Clinical Research and Operations, Project and People Management, and Quality and Risk Management across multiple global pharmaceutical companies. Expertise in Strategy Development, Clinical Program, Study Design and Execution, Clinical/Regulatory Writing and Submissions, Project Management, GCP Quality/Compliance, Analytics and Reporting Tool Development, People Management/Career Development, Continuous Process Improvement, and Implementation of Scientific/Process Training across multiple therapeutic areas. Particularly effective in building collaborative partnerships, both internally and externally to deliver results in a continually changing environment. Headed both groups and projects.
Experience
Sr Consultant, Clinical Operations Medical Writing Consulting
Jan 2020 — Present
Provide leadership/guidance to pharmaceutical and small biotech companies on clinical development projects. Support for clients includes program management/strategy, program/trial activation/execution, clinical operations, regulatory document writing, clinical support for data management activities, CRO oversight, SOP development, project management and performance analytics.
Education
Arcadia University
Bachelor of Arts - BA
Temple University College of Education
Masters of Education
Skills
- Career Development
- Pharmaceutical Industry
- Sop
- Fda
- Recruiting
- Life Sciences
- Clinical Trials
- Standard Operating Procedure (Sop)
- Strategy
- Diabetes
- U.s. Food and Drug Administration (Fda)
- Program Management
- Clinical Data Management
- Lifesciences
- Cardiovascular Disease
- Medical Writing
- Clinical Monitoring
- 21 Cfr Part 11
- Ich-Gcp
- Immunology
- Edc
- Oncology
- Protocol
- Drug Development
- Therapeutic Areas
- Cancer
- Gcp
- Ctms
- Validation
- Biomarkers
- Clinical Research
- Cardiology
- Interviews
- Clinical Development
- Process Improvement
- Project Management
- Infectious Diseases
- CRO
- Biotechnology
- Pharmaceutics
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