Relocation to Madison, Wisconsin is funded and required.
Summary of Responsibilities:
• According to the scope of work, and, under leadership of the Project Team, undertakes specified medical monitoring tasks and may serve as Lead Project Physician with oversight by functional line or Global Lead Project Physician.
• May partner with the business to develop new, and enhance existing, client relationships where possible.
• May contribute as a participant of the proposals team in medical/scientific discussions with clients.
• May perform site/investigator feasibility.
Builds relationships with investigators to support optimal recruiting and conduct of trials.
• Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company.
• Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines.
• Proactively identifies process and implementation issue/gaps and manages their effective escalation and resolution.
May participate in process improvement activities across Company.
• Performs medical data review – Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed.
• Develops, reviews and revise protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications.
• Prepares materials for investigator meetings.
• Actively participates in investigator meetings.
• Provides medical/scientific expertise to project teams.
• Responsible for medical and safety monitoring on assigned project.
• Interacts with inter-departmental and external consultants as appropriate.
• Participates in feasibility discussions relating to specific project proposals.
• Participates in project risk assessment activities.
• Provide out of hours medical cover, as required.
• 24/7 cover is required on a rotational basis.
• Flexibility to participate in client meetings across various time zones as needed to deliver business assignments.
Qualifications (Minimum Required):
• MD with residency completion or equivalent post graduate training.
• Company may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required: Speaking: English / Writing/Reading: English.
Experience (Minimum Required):
• Years of experience in the job discipline: new or up to 2 years.
• Other required work-related experiences: minimum 2 years.
• Knowledge of drug development and clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area: or equivalent academic experience can be submitted.
Preferred Qualifications Include:
• Board Certified MD
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