Overview
Clinical Scientist (Clinical Research/Clin Ops)
Description of Services
- 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
Minimum Years of Experience
- At least 2 years of 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, and identifying errors in data by performing data review that requires further clarification with the study sites
- Proficient in reviewing patient data and resolving discrepancies in areas such as adverse events, trends of adverse events, endpoint management; labs experience preferred
- Demonstrated oral and written communication skills
- Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. OneNote experience preferred
Educational Requirements
- Degree in Life Sciences
- BS/BA/MS/PhD