Our client, a leading pharmaceutical company is hiring a Study Assessment Planning Associate on a contract basis.
- Bachelors Degree required – B.S. A degree in Life Sciences or equivalent is preferred.
- Comprehensive understanding of clinical trial operations, including PK, PD, Laboratory Safety testing, and additional protocol assessments terminology.
- Knowledge of clinical design trial
- Understanding of Time and Event tables captured in clinical trial protocols
- Ability to proactively identify issues, make decisions, and resolve problems
- Demonstrates a strong understanding of the overall project goals and deadlines
Nice to have:
- Knowledge of general clinical research including Investigator site processes, site operations
- Knowledge of the pharmaceutical industry including the clinical and regulatory components.
- Background in QC
- Experience in robust data review
- Experience in protocol authoring
- Understanding of sample handling management, collection and testing tube experience, and shipping logistics"
- 3 + years of clinical trials in a pharma research or central clinical lab organization
- Desirable (nice to have) attributes/skills: Project Management, excel
- Management of clinical trial activities during study start up and execution
- Reviews the clinical protocol to identify study design, planned Assessments, and details of time and event schedules
- Provides assistance to ensure data quality and integrity for historical and on-going client trials
- Manages metadata required at a protocol level
- Data review responsibilities for assessment and visit matrix alignment
- Can manage working on multiple studies at any given time
- Drives and owns timelines for assigned projects
- Assists with development data quality for clinical trial database