Roger Trinh Talent Solutions is proud to partner with a dynamic Houston-based Biopharmaceutical company at the forefront of Cell and Gene Therapy (CGT) development. We seek an innovative Associate Director, Clinical Trial Manager with a proven track record in CGT-ONCO to lead cutting-edge initiatives. This is an opportunity to contribute remotely while providing strategic guidance to a team committed to collective success over individual gain. Join an environment of capital efficiency and platform prioritization, where our client is on the fast track for FDA approval and commercialization.

The ideal candidate for the role of Associate Director should be comfortable working in a start-up environment where resources may be scarce and hands-on work is required. They should be able to monitor and manage trial progress, optimize processes, and provide leadership to a developing organization while maintaining a flexible approach. A willingness to get into the trenches and work alongside the team is also necessary.

Key Responsibilities:

• Liaison with management staff to ensure ALL trial activities are compliant with protocol, local regulations, Code of Federal Regulations (CFR), ICH, and GCP guidance
• Manage site and vendor activities to ensure GCP compliance, including monitoring recruitment, data entry accuracy against source data, kit and sample shipment, and pharmacy activities; Answer operational questions from the site(s) and CRO/vendors; follow up and resolve queries and issues. Review field CRA monitoring reports. Seek supervisor/clinical team members’ input internally as needed.
• Carry out document management tasks to ensure Trial Master Files are collected and organized based on regulatory requirements and work closely with QA to ensure GCP compliance of TMF.
• Assist QA in SOP/WI development; assist QA in ensuring audit-ready files
• Answer site and vendor questions regarding trial operational and logistical matters
• Assist site(s) on strategies/activities to enhance recruitment/retention
• Participate in the review of protocol/amendment, study plans, site-level documentation, clinical data QC, and reports 
• Conduct site monitoring visits (including but not limited to site initiation closeout visits) either alone or accompany field CRA as needed
• Participate in Clinical vendor and clinical site evaluation that includes quote/budget review and negotiation and site initiation visits (SIV)
• Identify project risks and develop mitigation and contingency plans for management review.
• Ensure a positive and collaborative work environment with the site and vendors. Supports and communicates effectively.
• Keep senior management updated on progress and challenges and serve as liaison between clinical site(s) and external vendors.
• Support preparation of trial status, data, and other info for internal and external presentations; Participate in cross-functional meetings and process improvement initiatives across the departments
• Additional tasks as assigned

Requirements:

• Strong work ethics, experience, and a good understanding of regulatory requirements and GCP/ GxP
• B.S or higher degree in a life science discipline, a registered nurse certification, or equivalent, with 5+ years of oncology clinical trial experience (including full trial cycle: site selection, activation, data collection, database lock, site close out)
• Preference is given to candidates with prior experience working with large institutional oncology centers on cell therapy trials who have conducted site monitoring visits (initiation, interim, closeout)
• Proficient in using electronic data capture (EDCs), Trial Master Files (TMFs)
• Strong experience in managing clinical site and central lab service vendor activities and coordination
• Great attention to detail and data/document evaluation skills
• Ability to multi-task and adjust priorities while working with multiple CRAs across multiple sites, work independently in a matrix team environment across parties
• Ability to operate day-to-day work independently in a GCP-compliant manner based on general instructions on assignments and as outlined in protocol and study plans
• High proficiency with all Microsoft applications, including Word, PPT, Excel, Outlook, Teams
• Excellent interpersonal, collaborative, and time management skills
• Business fluent in English, Excellent oral and written communication skills across all levels of the organization
• Able to travel domestically and internationally as needed (20-30%)
• Reside in Houston or Texas, preferred, but open to all US states.

Please feel free to contact roger@rogertrinh.com about this opportunity.