Clinical Scientist - FSP

Parexel; Lincoln (NE); Remote; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Clinical Scientist to support the clinical/scientific conduct of complex studies in line with ICH-GCP. The role includes medical monitoring, data reconciliation, and preparation of materials for governance and stakeholder meetings.

The ideal candidate has 2+ years of pharma or clinical development experience, oncology posting familiarity, and strong communication skills. Remote-friendly with potential on-site requirements in the US.

Qualifications

• 2+ years in pharmaceutical or clinical drug development in the last 5 years.
• TA-specific oncology IDV and GSM experience preferred.
• Indication-specific experience preferred.
• Experience reviewing and resolving study data issues and data queries with sites.

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, protocol deviation management).
• May support a single study or multiple studies.
• May lead a study with limited scope (e.g., Survival Follow-up).
• Interact with internal and external stakeholders (study sites, committees) to support study objectives.

Skills

Adverse events data review

Med monitoring

Data reconciliation

Communication skills

MS Office proficiency

OneNote experience

Attention to detail

Education

Degree in Life Sciences

BS/BA/MS/PhD

Tools

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.