Jobs at 4D Molecular Therapeutics

The Clinical Trial Manager (Contract) will support the Company's clinical trial activities and report to the Director of Clinical Operations. The role is responsible for managing the day to day operations of one or more phase 1-3 clinical trials, including trial start up, conduct and close out activities. Location: Emeryville, California or Remote, United States.

Trial Management:

• 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 findings and ensure audit-ready condition of clinical trial documentation including central clinical files
• Participate in service provider selection process as a part of outsourcing activities
• Proactively identify, with the support and guidance from Senior Clinical Operations staff, and support development of plans and resolution of project issues and participate in process improvement initiatives as required
• Support 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
• Ensure tracking and review of protocol deviations and assess impact on study data
• Develop and manage study budget and maintain within financial goals; review and approve clinical invoices against approved budget
• Provide oversight for forecasting of clinical supplies, including study drug and supplies

Department Management:

• May manage and/or oversee work of junior Clinical Operations staff
• May support development and review of Clinical SOPs and other department initiatives
• Travel as needed to sites, conferences, industry meetings
• Other duties as may be assigned

Education:

• B.A./B.S. degree in Science

Experience:

• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting a retina clinical trial
• Global APAC experience desired

Other Qualifications/Skills:

• 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 including Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for development and update of clinical study timelines

Travel: 5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: substantial movements of the wrists, hands, and/or fingers. Fingering: picking, pinching, typing or otherwise working primarily with fingers. Talking: expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly. Sedentary work involves sitting most of the time.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).