Clinical Scientist - FSP

Parexel; Sacramento (CA); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Clinical Scientist to assist the CS Protocol Lead and study team in the clinical/scientific conduct of clinical studies, including adjudication support and medical monitoring. The role supports remote work across studies, collaborating with sites and committees to meet study objectives.

The candidate will review data, resolve discrepancies, maintain training, and ensure compliance with Parexel standards and ICH-GCPs while preparing materials for meetings and milestones.

Qualifications

• Review patient data and resolve discrepancies including adverse events and endpoints.
• Strong written and oral communication skills are required.
• Proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint); OneNote is a plus.

Responsibilities

• Assist the CS Protocol Lead and study team with clinical/scientific conduct of studies.
• May support a single study or multiple studies.
• May lead a study with limited scope.
• Interact with internal and external stakeholders to support study objectives.

Skills

Data review

Communication skills

MS Office

OneNote

Education

Life Sciences degree

BS/BA/MS/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.