Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.
Conduct and report all types of onsite monitoring visits.
Perform CRF review, source document verification, and query resolution.
Support study startup, site communication, and audits.
PSI is a leading CRO with 30+ years in the industry, offering stability and innovation. We focus on quality and on-time services across therapeutic indications, with friendly and supportive colleagues.
Work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards.
Build and maintain relationships with clinical sites and investigators, focusing on subjects' rights, safety, and well-being.
Conduct and report all types of onsite monitoring visits, including CRF reviews and source document verification.
PSI is a leading Contract Research Organisation with 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across a variety of therapeutic indications.