Clinical Development Expert

4 days ago

Washington, Washington, D.C., United States Tunnell Government Services Full time

We are seeking a highly skilled Clinical Development Expert to join our team at Tunnell Government Services, Inc.

Estimated Salary: $140,000 - $180,000 per year

About the Company

Tunnell Government Services, Inc. is a leading provider of scientific, medical, and technical expertise to the government sector.

We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals.

Job Description

The successful candidate will be responsible for providing subject matter expertise in clinical development and operations in support of investigational products, including vaccines, therapeutics, biologics, and devices.

Key Responsibilities:

  • Provide SME guidance on clinical development and operational activities for observational studies and Phase 0 through IV clinical trials
  • Develop and implement risk assessment and mitigation strategies
  • Ensure regulatory processes and guidelines are followed, including co-authoring and reviewing regulatory submissions to the US Food and Drug Administration (FDA)
  • Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals

Required Skills and Qualifications

To be successful in this role, you will need:

  • At least 10+ years clinical development and operations experience in positions with graduated responsibilities
  • Application of an advanced degree(s) in nursing, biological sciences, public health, medicine or pharmacy or biotechnology and biopharmaceuticals or related field with commensurate experience(s)
  • Demonstrated working knowledge of ICH-GCP guidelines
  • Experience managing late stage (phase 2 and 3) clinical trials

Benefits

As a valued member of our team, you will enjoy:

  • A competitive salary and benefits package
  • The opportunity to work on high-profile government contracts
  • A collaborative and dynamic work environment

Others

Please note that some of our client contracts require us to validate that our employees and contractors are fully vaccinated against COVID-19, subject to legal requirements.

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