The Site Director manages overall clinical site operations, including identification, start-up, monitoring, and close-out of Phase I-IV studies. They ensure patient safety, data accuracy, and compliance with ICH-GCP guidelines and regulatory requirements.
Lead end-to-end clinical supply chain operations for international studies, including planning, forecasting, and distribution. Oversee key vendors and partner with internal stakeholders to ensure clinical materials are available and budgets are met.
Lead data management activities for clinical studies from database start-up through lock, including vendor oversight and the creation of essential DM documentation. Ensure data accuracy and consistency for regulatory submissions while managing project timelines and budgets.
Support the clinical development strategy and execution of domestic and international drug development programs across all phases. Collaborate cross-functionally to ensure high-quality clinical data, support regulatory interactions, and oversee safety monitoring.
Oversee the planning and execution of CMC strategies and drug product formulations to support development programs. Manage relationships with CDMOs and CROs while drafting regulatory documents for IND and NDA submissions.
The Site Director manages overall clinical site operations, including identification, start-up, monitoring, and close-out of Phase I-IV studies. They ensure patient safety, data accuracy, and compliance with ICH-GCP guidelines and regulatory requirements.
Responsible for overall clinical site management, including identification, start-up, monitoring, and close-out of Phase I-IV studies. Ensures patient safety, data accuracy, and compliance with ICH-GCP guidelines and regulatory requirements.
The Site Director manages overall clinical site operations, including identification, start-up, monitoring, and close-out of Phase I-IV studies. They ensure patient safety, data accuracy, and compliance with ICH-GCP guidelines and local regulatory requirements.
Oversee clinical supply chain operations, including drug supply planning, forecasting, and distribution for domestic and international studies. Manage third-party vendors and ensure compliance with GxP documentation and trial master file requirements.
The Vice President of Clinical Development will oversee the strategic planning and execution of domestic and international drug development programs. This role involves leading clinical trials, ensuring regulatory compliance, and managing medical oversight including safety and pharmacovigilance.
The Manager/Senior Manager, Contracts will provide organization-wide contract support across research, manufacturing, clinical, finance, and general operations, focusing on reviewing, drafting, and negotiating a wide range of agreements. This role is also responsible for managing the entire contract lifecycle, ensuring compliance, and reporting real-time status updates to management.
