Clinical Scientist - FSP

Parexel; Trenton (NJ); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel seeks a Clinical Scientist to support the CS Protocol Lead and study teams in the clinical and scientific conduct of trials. Responsibilities include adjudication support, medical monitoring, and data reconciliation preparation of meeting materials.

The role may lead small studies, interact with sites and committees, and ensure adherence to ICH-GCP and Parexel standards. A Life Sciences background and 2+ years in pharma or clinical development are preferred.

Qualifications

• Degree in Life Sciences.
• BS/BA, MS or PhD preferred.
• Pharma/clinical development experience is desirable.

Responsibilities

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies, including adjudication support and medical monitoring.
• Prepare imaging data reconciliation and meeting materials; manage protocol deviations.
• Interact with study sites and committees to support trial objectives.

Skills

Data review & discrepancy resolution

Oral & written communication

MS Office proficiency

OneNote experience

Education

Life Sciences degree

Bachelor of Science

Master of Science

PhD

Tools

Microsoft Office

OneNote

Job description

Job Overview:

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:

Clinical Trial Operational Delivery

• 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


• May support a single study or multiple studies


• May lead a study with limited scope (e.g., Survival Follow-up)


• 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 and timely 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:

• Proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs experience preferred


• Demonstrated oral and written communication skills


• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred.

Knowledge and Experience:

• At least 2 years Pharmaceutical and/or clinical drug development experience (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 5 years required


• TA-specific experience required for postings in Oncology IDV and GSM preferred.


• Indication specific experience preferred


• Experience reviewing and resolving study related data issues such as issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required

Education:

• Degree in Life Sciences


• Bachelor of Science/Bachelor of Arts/Master of Science/PhD

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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.