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REMOTE

Salaried with PTO and Holidays included

Therapeutic area: Vaccines

40 hours a week

Vaccine / Immunology experience is required

Global experience is required

Responsibilities:

• Create and drive study level timeline

• Develop overall feasibility concept and enrollment plan with input from Clinical Oversight Monitors (COMs)

• Develop and manage study budget

• Provide input on operational aspects of the protocol

• Ensure regulatory compliance and GCP compliance

• Responsible for oversight of TMF with periodic audits

• Responsible for/contribute to vendor selection and management including issue escalation

Education:

• At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.

Experience:

• As a guide, a minimum 4+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.

• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

• Experience in overseeing global clinical trials (pharmaceutical or research institute).

• Budget forecasting and management.

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