Senior Clinical Trial Manager - Global Cross‑Functional Lead

Structure Therapeutics; South San Francisco (CA); Vor Ort; USD 171.000 - 218.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Equity

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Zusammenfassung

Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to join our Clinical Operations team in California.

You will oversee global trials, manage CROs and service providers, and coordinate cross‑functional activities to ensure timely, on‑budget delivery of late‑stage studies. The SCTM collaborates with teams in the US and Shanghai, supports regulatory readiness, and ensures SOP compliance.

Qualifikationen

• Bachelor’s degree or equivalent in scientific or healthcare discipline preferred.
• Minimum 7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope.
• Minimum 3+ years study management experience in clinical and drug development.
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is
• Experience working on global teams is desired, Asia‑Pacific and EU highly.

Aufgaben

• Leads and coordinates global cross‑functional study teams through all study stages (start‑up, conduct, close‑out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and elevate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.
• Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues/risks, escalates as needed and recommends/implements
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review/clean up.
• Coordinate with Lead and Finance to track the financial status against budget.
• Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or elevate issues appropriately.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization; implementation of PI Training, site monitor training, etc.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational

Kenntnisse

MS Office

Regulatory knowledge

Ausbildung

Bachelor's degree or equivalent (scientific or healthcare discipline preferred)

Tools

EDC

CTMS

eTMF

Jobbeschreibung

Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to join our Clinical Operations team in California.

You will oversee global trials, manage CROs and service providers, and coordinate cross‑functional activities to ensure timely, on‑budget delivery of late‑stage studies. The SCTM collaborates with teams in the US and Shanghai, supports regulatory readiness, and ensures SOP compliance.