Summary:
• 20 plus years experience in the pharmaceutical, medical device, and CRO industries
• 10 years in National Management and Training
• Knowledgeable in clinical trial operations from feasibility through to closeout.
• Experience in FDA regulations 21 CFR, Parts 11,50,54, and 56
• Skillful in maintaining the regulatory binder, which houses essential documents such as1572, source
documents, DOA, training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment &
Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures
(SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF)
document.
• 2 years Phase 4 research projects
• Pharmacovigilance Leadership
• Clinical Research Site Activation Coordinator
Specialties:
Sales, Account Management and Project Management. Extensive medical knowledge and experience with multiple therapeutic areas. Proven track record in both the large and small pharma environments and extensive experience with CRO’s. Expert with contract negotiations with health systems at CFO and CEO level.Summary: • 20 plus years’ experience in pharmaceutical, medical device, and CRO industries • 10 years in National Management and Training • Knowledgeable in clinical trial operations from feasibility through to closeout. • Experience in FDA regulations 21 CFR, Parts 11,50,54, and 56 • Skillful in maintaining the regulatory binder, which houses essential documents such as1572, source documents, DOA, training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF) document. • 2 years Phase 4 research projects • Pharmacovigilance Leadership • Clinical Research Site Activation Coordinator Specialties: Sales, Account Management and Project Management. Extensive medical knowledge and experience in More...
Claudia Nelson
Quality Assurance Consultant@Self-employed
Verified
Claudia Nelson, a self-employed Quality Assurance Consultant, offers expert services in quality management to businesses across various sectors. She carries out systematic activities to determine whether products or services meet specified quality criteria. Her responsibilities include developing quality control processes, identifying and setting quality standards, and assessing the effectiveness of quality control programs. Claudia has proven proficiency in identifying faults, recommending solutions, and ensuring that businesses meet the necessary legal compliance and customer expectations. She leverages her extensive knowledge and experience to help businesses improve their processes, enhance customer satisfaction, and ultimately boost their bottom line.More...
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As Elizabeth Korsah, a Data Entry specialist at Hvivo, I have successfully managed and organized large volumes of data with utmost accuracy. I have demonstrated exceptional attention to detail and ability to multitask, leading to increased efficiency in data management. I have also developed and implemented new data entry protocols that improved data accuracy and speed. My proficiency in various data entry software and tools has been instrumental in streamlining the data entry process.More...