Sr. Clinical Trial Manager

Structure Therapeutics, Inc.; South San Francisco, Northern (CA, KY); Hybride; USD 171 000 - 218 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

401k match

Unlimited PTO

Paid holidays

Résumé du poste

Structure Therapeutics, Inc. is seeking a Sr. Clinical Trial Manager to lead global clinical trials within our Clinical Operations team. The role manages internal stakeholders, CROs, and service providers, ensuring trials are conducted on time and within budget across multinational sites.

The successful candidate will have 7+ years in clinical research, 3+ years in study management, and a strong understanding of FDA/EU regulations. A Bachelor’s degree in a science or healthcare field is required.

Qualifications

• Bachelor’s degree or equivalent in a scientific or healthcare discipline.
• 7+ years of Clinical Research Associate or related function with increasing responsibility.
• 3+ years study management experience in clinical and drug development.
• Experience selecting, managing, and overseeing sites, CROs, and service providers in global studies.
• Familiarity with SOP development and implementation; experience working on global teams.

Responsabilités

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• Oversees RFP/RFI processes, budgets, proposals, and complex agreements with CROs and service providers.
• Provides oversight to CROs and service providers to coordinate clinical study activities.

Connaissances

MS Office

Regulatory knowledge (FDA/EU)

Formation

Bachelor’s degree or equivalent (scientific/healthcare)

Outils

EDC/CTMS/eTMF systems

Description du poste

About Us:

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary:

Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to be part of our Clinical Operations team. This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The SCTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The SCTM will focus on the management and support of multinational, multicenter, late stage studies and may assume responsibility for additional studies/indications as applicable. The SCTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The SCTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.

Job Responsibilities

• 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 escalates 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

Qualifications:

Education

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

Experience

• Minimum of 7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 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

Core Competencies, Knowledge and Skill Requirements

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.

Travel Required:

Up to 30%

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $171,000 - $218,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.