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
- 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:
- Bachelor of Science/Bachelor of Arts/Master of Science/PhD
