4D Molecular Therapeutics

Powering the Future of Genetic Medicines

Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

15 days ago

Salary

$150K - $178K / year

Bachelor Degree6 yrs expEnglishGoogle Cloud Platform

Job Description

• Support the Company's clinical trial activities • Manage day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities • Serve as the primary contact for managing protocol execution, including oversight of the CRO, study service providers, and consultants • Lead cross-functional study execution team • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs • Assist in preparation and review of clinical trial documentation • Ensure that the Trial Master File (TMF) is set up and maintained appropriately • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation • Manage clinical trial budgets, providing ongoing financial reporting and projections • Perform and manage data review process on an ongoing basis • Perform site visits as needed.

Job Requirements

  • B.A./B.S. degree
  • 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
  • Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Strong clinical study management skills
  • Understanding of regulatory frameworks applicable to interactions with HCPs, payers, advocacy, and other business partners
  • Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met
  • Excellent communication skills to effectively disseminate information to project team and outside parties
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
  • Working knowledge of MS Project for development and update of clinical study timelines.

Benefits

  • Health insurance
  • Flexible work arrangements
  • Professional development opportunities

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