Clinical Scientist - FSP

Parexel; Dover; Remote; GBP 42,000 - 65,000; Full time

Job summary

Parexel is seeking a Clinical Scientist to assist the CS Protocol Lead and study team with the clinical and scientific conduct of clinical studies. Responsibilities include adjudication support, medical monitoring, imaging data reconciliation, and preparing materials for meetings.

The role may support one or multiple studies and interact with internal and external stakeholders to achieve study objectives while complying with Parexel standards and ICH-GCP guidelines.

Qualifications

• Degree in Life Sciences or higher.
• Experience reviewing data and resolving study data issues.
• Strong communication skills.

Responsibilities

• Assist the CS Protocol Lead with clinical/scientific conduct of studies (adjudication, medical monitoring, imaging data reconciliation, meeting materials).
• Support one or multiple studies and may lead a study with limited scope.
• Interact with study sites, committees and other stakeholders to support study objectives.
• Ensure compliance with Parexel standards, ICH-GCP, and required training; maintain accurate timesheets and CV updates.

Skills

Data review & discrepancy resolution

Oral & written communication

MS Office proficiency

Education

Degree in Life Sciences

BSc/BA/MSc/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.