Clinical Scientist - FSP

Parexel; Raleigh (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

Parexel is seeking a Clinical Scientist to support the clinical/scientific conduct of clinical studies, including adjudication support, medical monitoring, and imaging data reconciliation. The role involves preparing meeting materials, managing protocol deviations, and liaising with study sites and cross-functional teams.

Qualified candidates have oncology experience, 2+ years of medical monitoring (or equivalent), and a Life Sciences degree.

Qualifications

• Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience
• If no degree in Life Sciences, must have Bachelor's degree with significant experience in clinical development (>5 years)
• Oncology experience is required
• 2 years medical monitoring experience preferred
• Experience with adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, and protocol deviation management

Responsibilities

• Assist with clinical/scientific conduct of clinical studies (adjudication support, medical monitoring, imaging data reconciliation)
• Prepare materials for meetings and manage protocol deviations
• Interact with study sites and committees to support study objectives
• Ensure Parexel standards and compliance with ICH-GCPs and internal processes

Skills

Oral and written communication

MS Office Suite

Advanced Excel

Proficient in English

Willingness to travel

Education

Life Sciences degree (BSc/MSc/PhD)

Alternative: +Bachelor's with >5 years clinical development

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Purpose:

The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management).

Key Accountabilities:

May include but not limited to the following:

Clinical Trial Operational Delivery

• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• Liaises with cross-functional lines as appropriate
• May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes,
• ICH-GCPs and other applicable requirements

Skills

• Demonstrated oral and written communication skills
• MS Office Suite Experience Required- including Word, Excel, and Power Point
• Advanced Excel skills required (pivot tables, v-lookups)
• Proficient in written and spoken English
• Willingness to travel as required for key company meetings

Knowledge and Experience

• Pharmaceutical experience beneficial but not required
• Oncology experience is required
• 2 years medical monitoring experience preferred
• Experience with adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, and protocol deviation management

Education

• Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience
• If no degree in Life Sciences, must have Bachelor's degree with significant experience in clinical development (>5 years)

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.