Clinical Scientist - FSP

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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