Sr. Clinical Trials Manager

Location
Emeryville, CA, United States
Posted
Sep 09, 2020
Ref
564038748
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics (4DMT) is a gene therapy company with a transformative discovery platform—Therapeutic Vector Evolution—that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development. Join us in creating the ultimate gene therapy products to cure genetic diseases in children and adults. 4D Molecular Therapeutics headquarters are located in Emeryville, CA.

GENERAL SUMMARY:

4DMT is in need of a motivated and experienced Senior Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director, Clinical Operations role within the retina program, and will be responsible for oversight and management of the day to day operations of multiple phase 1-2 clinical trials including trial start up, conduct and close out activities.

RESPONSIBILITIES:
  • Trial Management: 75% of TIME
  • 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
  • Establish 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
  • Responsible for and participates in service provider selection process as a part of outsourcing activities
  • Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required
  • Responsible for assessing operational feasibility, recommending study execution plan and site selection
  • 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 budget
  • Provides oversight for forecasting of clinical supplies, including study drug and supplies


  • Department Management: 25% of TIME
  • Manage and/or oversee work of junior Clinical Operations staff
  • 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


QUALIFICATIONS:
  • Education:
  • Bachelor's Degree


  • Experience:
  • 6+ years of clinical research experience within the Biotech or similar industry


  • Skills:
  • (non-technical and technical 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 leadership 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 developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
  • Extensive 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




4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities