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4D Molecular Therapeutics logo
4D Molecular Therapeutics

Powering the Future of Genetic Medicines

Clinical Trial Manager

Clinical ResearchClinical ResearchOtherRemoteSeniorTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

95 days ago

Salary

$150K - $172K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglishGCP

Job Description

Clinical Trial Manager

4D Molecular Therapeutics

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial • Lead cross-functional study execution team in support of study deliverables • Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership • 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 such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files • Participates in service provider selection process as a part of outsourcing activities • Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required • Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations • Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents • Manage clinical trial budgets, providing ongoing financial reporting and projections • Negotiate and finalize site contracts and budgets • Perform and manage data review process on an ongoing basis • Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed • Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues • Ensures tracking and review of protocol deviations and assesses impact on study data • Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget • Provides oversight for forecasting of clinical supplies, including study drug and supplies.

Job Requirements

  • 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, and experience with, regulatory framework 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
  • Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
  • Clinical research knowledge and cross-functional understanding of clinical trial methodology
  • Excellent organizational, conflict resolution, prioritization and negotiation skills
  • Proven ability in creative problem-solving and exercising sound judgment
  • Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
  • Ability to handle a high volume of highly complex tasks within a given timeline
  • Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
  • 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.

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