Edison-New Brunswick Metro Area, NJ
The Sample Manager is an expert and responsible for biological sample handling, ensuring the procedure for collection, storage and shipment of specimens for measurements of clinical samples of R&D Translational Medicine and Development. The Sample Manager is responsible for study set-up of clinical trials based on defined standards and timelines.
The Sample Manager is a key partner for the clinical operation teams and experts for bioanalytical departments. He/she manages the studies in compliance with the standards to support a flawless conduct of clinical trials. In addition, he/she is expert at management of clinical samples including, but not limited to, pharmacokinetic (PK), anti-drug antibodies (ADA), anti-drug conjugates (ADC) and biomarkers (BM).
Excellent knowledge in clinical development
Proficient in English (written and verbally).
Basic knowledge in bioanalytical methods.
Basic knowledge of conducting Oncology clinical trials.
Creating a sample management plan per study
Demonstrates high motivation for the job.
Self-motivated and interested working in a complex environment.
Ability to handle multiple tasks, to prioritize, detail oriented and highly accurate.
Working in a regulated environment according to GLP / GCLP / CAP/CLIA standards.
Anticipates complex problems and proactively works to minimize their impact.
Very good organizational skills.
Excellent interpersonal and communication skills, interfacing with cooperating departments and external partners.
Team player keen on receiving and sharing knowledge/expertise in a global team.
BS in biology or elated scientific discipline
0-3 years experiemce working in clinical development