structuretx

structuretx

Sr. Clinical Trial Manager (MP)

South San Francisco, California · Senior

Sponsorship not specified$171k-$218kDetected 20 days ago
GCPProject ManagementExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationMicrosoft Office

About the role

  • 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.

Responsibilities

  • 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.
  • 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.
  • Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
  • 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.

Requirements

  • 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
  • PC literacy required
  • Travel Required: Up to 30%
  • Bachelor's degree or equivalent (scientific or healthcare discipline preferred)
  • 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.

Skills

  • Core Competencies, Knowledge and Skill Requirements

Compensation

  • 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.
  • At Structure, base pay is only one part of your total compensation package.

Benefits

  • 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.
  • Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.

Company info

  • 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.
  • 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.
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