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4D Molecular Therapeutics logo
4D Molecular Therapeutics

Powering the Future of Genetic Medicines

Associate Clinical Trial Manager

Location

United States

Posted

82 days ago

Salary

$130K - $152K / year

Seniority

Mid Level

Bachelor Degree5 yrs expEnglishGCP

Job Description

Associate Clinical Trial Manager

4D Molecular Therapeutics

• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management • Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing • Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF) • Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking • Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers • Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines • Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes) • Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders) • Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance • Assist with the development of site tools and clinical trial start-up activities • Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations • Assist in tracking of trial IP and development of Pharmacy Manuals • Participate in study vendor set up and specification process, as appropriate • Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities • Assist with tracking of clinical trial progress including status update reports, as requested • Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking • Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation • Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates • May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues • Willing to travel as business needs demand (<5% anticipated) • Other duties as may be assigned

Job Requirements

  • A./B.S. degree required
  • At least 5 years of work experience supporting clinical trials, with some experience supporting ophthalmology studies (required)
  • Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
  • Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, SharePoint and Outlook
  • Ability to prioritize and manage competing priorities
  • Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners.

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