Study Assessment Planning Associate

08648, Lawrenceville
Nov 18, 2020
Required Education
Bachelors Degree
Position Type

Our client, a leading Pharmaceutical Company is hiring a Study Assessment Planning Associate on a contracting basis.

Location: Lawrenceville, NJ

Must have:
• 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"
" 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 BMS 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 client clinical trial database
3 + years of clinical trials in a pharma research or central clinical lab organization

Desirable (nice to have) attributes/skills: Project Management, excel

Bachelor’s Degree required - B.S. A degree in Life Sciences or equivalent is preferred.