The Manager will oversee Trial Master File (TMF) activities, ensuring all clinical study documentation is accurate, complete, and inspection-ready. They will also manage the Clinical Trial Management System (CTMS) and provide training to study teams on quality documentation practices.
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 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.
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.
