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Parexel

Clinical Scientist - FSP

Posted 2 Days Ago
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Remote
Hiring Remotely in United States
Junior
Remote
Hiring Remotely in United States
Junior
Supports clinical and scientific conduct of clinical studies, including adjudication, medical monitoring, imaging data reconciliation, meeting materials, protocol deviation management, and study data review. The role may support multiple studies, interact with study sites and committees, and lead limited-scope studies. Responsibilities also include resolving data discrepancies, reviewing patient and medical record information, maintaining compliance with ICH-GCP and company processes, and completing required administrative tasks.
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When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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  

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.

Parexel Hackensack, New Jersey, USA Office

Hackensack, United States

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