Melanie Fein M. D.
Director of Medical Strategy and Oversight at Spaulding Clinical Research
- Role
- Director of Medical Strategy and Oversight Spaulding Clinical Research at Spaulding Clinical Research, Llc
- Location
- West Bend, WI, US
- LinkedIn followers
- 500 followers
About Melanie Fein M. D.
Highly dedicated, experienced, hands on investigator/medical director. Passionate about the conduct of clinical trials, implementation and supervision of high quality, efficient systems and training staff in clinical trial processes.Recognized for delivering high quality, timely trials, while ensuring safety and protocol/SOP/GCP and ICH compliance.Expertise includes :Conduct of Clinical Trials - 18years of experience and involvement in over 360 phase one and two trials.Analysis of, set up, implementation and supervision of operational and clinical systems and process improvements for clinical trial centers.Writing of functional SOPsCreating content of source and generic trial documents Design and implementation of training programs for various trial departmentsImplemented “Research University” a week long training program offering a didactic overview of clinical trials. Quality control systems development and implementation.Business Development Supervision of summer intern programs to give students exposure to clinical trials
Experience
Director of Medical Strategy and Oversight Spaulding Clinical Research
Spaulding Clinical Research, Llc
Jul 2023 — Present · WI, US
Education
University of the Witwatersrand
MBBCH
Skills
- Drug Development
- Gcp
- Clinical Monitoring
- Clinical Trials
- Regulatory Affairs
- Clinical Development
- Oncology
- Protocol
- Pharmaceutical Industry
- Sop
- CRO
- Fda
- Ich-Gcp
- Clinical Research
- Clinical Pharmacology
- Edc
- Therapeutic Areas
- Ctms
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