Sr. Clinical Trial Manager

3 weeks ago

Emeryville, United States 4D Molecular Therapeutics Inc. Full time

GENERAL SUMMARY:

4DMT is recruiting for a motivated and experienced Sr. Clinical Trial Manager to support the Company's clinical trial activities. This position reports to the Associate Director/ Director of Clinical Operations. This role will be within the ophthalmology program and will be responsible for management of the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities.

RESPONSIBILITIES:

* Responsible 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 (SET) 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 Sr. CTM or AD/Director of Clincal 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
* 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

QUALIFICATIONS:

Education:

* Bachelor's Degree

Experience:

* 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management

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 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



Base salary compensation range:

Outside of Bay Area range: $170k/yr - $195k/yr

Bay Area Range: $187k/yr - $208k/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.

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