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
...Supermarkets is a large volume supermarket chain with nine ShopRite stores located in Northwest New Jersey. Our locations are in the... ...We are looking for applicants with experience in managing a retail store with high volumes exceeding $30M in sales annually and a...
...off Looking for job security, a safe work environment, advancement opportunities and... ...flexibility. We work no evening hours, weekends or holidays! Working alone or in pairs,... ...opportunity for anyone currently working as a construction or warehouse worker, laborers,...
...Purpose: ~ To Enforce the Safety Program on the job site, manage safety documentation, and communicate with the Safety Director... ...Superintendents, Project Managers, and crew to maintain an accident-free construction site. ESSENTIAL JOB DUTIES: Maintain a safe and...
...voice assistants that actually talk like people. This marks a new beginning for voice as the world's default interface. We will... ...seeking to add a handful of motivated, hungry early career software engineers to our team at Vapi AI! Early career engineers with us will dive...
...are offering a long-term contract employment opportunity for a Help Desk Analyst II in Pittsburgh, Pennsylvania. The selected candidate... ...operation of IT services. Responsibilities: Provide hands-on technical support, diagnosing and resolving hardware, software...