Provide scientific input to clinical development and scientific affairs activities. Contribute to clinical strategy, protocol development, data analysis, reporting of results, regulatory documents, and external activities. Represent clinical research / scientific affairs at internal and external forums.
The Manager, Bio-Sample Operations is a role responsible for supporting the oversight of the complete lifecycle of bio-samples in clinical trials including tracking of samples, ensuring that samples are collected, processed, stored, and disposed of in accordance with study Protocols, Informed Consent Forms (ICFs), and relevant laboratory documents. This role involves the management and oversight of central labs, specialty labs, and a variety of responsibilities associated with sample management across all clinical programs.
The Clinical Research Scientist (CRS) is vital, using scientific and clinical training to support launch and commercialization activities. The CRS works with medical affairs, development, and business unit brand teams to meet patients' needs and enhance customer experience. Activities include clinical plan development, local clinical trials, adverse event reporting, and medical outreach to thought leaders.