Clinical Scientist - FSP

Parexel; Des Moines (IA); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is recruiting a Clinical Scientist to support the clinical/scientific conduct of studies, including adjudication, medical monitoring, and data reconciliation. You will collaborate with the CS Protocol Lead and study team to ensure high-quality trial delivery.

The role may involve supporting one or more studies, with potential limited leadership on specific areas, and interaction with sites and committees to meet study objectives. Parexel emphasizes adherence to training and processes.

Qualifications

• At least 2 years Pharmaceutical and/or clinical drug development experience in the last 5 years.
• TA-specific experience preferred for Oncology IDV and GSM postings.
• Indication-specific experience preferred.
• Experience reviewing and resolving study data issues and data queries with site clarification.

Responsibilities

• Assist 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, and 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.) to support clinical study objectives.

Skills

Data review & discrepancy resolution

Medical monitoring

Communication skills

Microsoft Office proficiency

Education

Life Sciences degree

Bachelor/Master/PhD in Life Sciences

Tools

Outlook

Word

Excel

PowerPoint

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.