Provides medical oversight of assigned clinical studies in the duty as a medical monitor
Often serves as primary medical contact for customers for assigned clinical studies
Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
Responsible for protocol design and development, upon request
Provides input into protocol amendments
Develops and delivers project-specific and therapeutic training to project team members and clinical site staff
Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data

Requirements

Provides medical oversight of assigned clinical studies in the duty as a medical monitor
Often serves as primary medical contact for customers for assigned clinical studies
Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
Responsible for protocol design and development, upon request
Provides input into protocol amendments
Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines
Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs)

Benefits

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical oversightprotocol designprotocol amendmentsclinical data reviewdrug safetypharmacovigilancetherapeutic trainingstudy start upfeasibility assessmentsubject identification

Soft Skills

communicationleadershiptrainingcollaborationcustomer interaction

Certifications

Good Clinical Practice (GCP)