Clinical Scientist- FSP

Regulatory Toolkit; Brewster Heights (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Clinical Scientist to support clinical studies and medical monitoring, with duties including adjudication support, protocol deviation management, and study materials preparation.

You will collaborate with cross-functional teams, interact with sites and committees, and contribute to data reconciliation and regulatory compliance, leveraging strong communication and life sciences knowledge.

Qualifications

• Minimum 2 years medical monitoring experience.
• Bachelor/Master/PhD in Life Sciences.
• Experience in regulatory or clinical development is preferred.

Responsibilities

• Assist the CS Protocol Lead and study team with clinical/scientific conduct of studies (e.g., adjudication support, medical monitoring, imaging data reconciliation, preparation of meeting materials, protocol deviation management).
• May support a single study or multiple studies and liaise with cross-functional lines as appropriate.
• Interact with internal and external stakeholders (study sites, committees) in support of clinical study objectives.
• Ensure compliance with Parexel processes, ICH-GCPs and other applicable requirements.

Skills

Oral and written communication

MS Office Suite

Proficient in English

Proficient in local language

Willingness to travel

Education

Bachelor/Master/PhD in Life Sciences

Clinical development experience >5 years (if no Life Sciences degree)

Tools

MS Office

Job description

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

PXL is hiring a Clinical Scientist!

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
• Proficient in written and spoken English
• Proficient in local language (as applicable)
• Willingness to travel as required for key company meetings

Knowledge and Experience

• Pharmaceutical experience beneficial but not required
• Therapeutic Area (TA) specific experience beneficial
• 2 years medical monitoring experience preferred

Education

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

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.