Sr. Clinical Trial Manager

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.