Clinical Scientist – FSP

Job Description:

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication, medical monitoring, imaging data reconciliation, preparation of meeting materials, and protocol deviation management
• Support a single study or multiple studies
• Lead a study with limited scope, such as Survival Follow-up
• Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
• Complete required training curriculum
• Complete timesheets accurately and on time
• Submit expense reports as required
• Update CV as required
• Maintain working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements

Requirements:

• At least 2 years Pharmaceutical and/or clinical drug development experience 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, including issued queries, resolved queries, medical record review, and identifying data errors requiring clarification with study sites
• Proficient in reviewing patient data and resolving discrepancies involving adverse events, adverse-event trends, endpoint management, and labs experience preferred
• Demonstrated oral and written communication skills
• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required
• OneNote experience preferred
• Degree in Life Sciences
• Bachelor of Science, Bachelor of Arts, Master of Science, or PhD