Senior Clinical Trial Manager (Sr. CTM)

The Opportunity

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

 Responsibilities 

• Lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.
• Preparation of study budgets and timelines. Manages project timelines and vendor performance to meet departmental and corporate goals. Manages study budget and payment process for all clinical trial vendors including investigative sites.
• Monitors and tracks clinical trial progress and provide status update reports.
• Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central imaging).
• Selection of CRO study staff and coordinating training including documentation. Hires, trains and oversees study Field Monitors (e.g., review of all trip reports) and provides guidance on site issues.
• Leads with minimal supervision in the planning of investigator meetings and making presentations, as required.
• Leads the review of clinical data at the CRF, data listing, and report table levels.
• Leads the Study Execution Team meetings for individual studies, as appropriate. Partners with other research and development groups to achieve deliverables.
• Participates in Site Initiation Visits (SIVs) as required. Co-Monitors regional sites for adherence to protocol and GCP as required. Identifies and escalates site, vendor and study related issues to supervisor, as appropriate. 
• Assess feasibility of enrollment across different neurodegeneration indications by providing assessment of timelines/rate of patient availability.
• Assist in the development of RFIs, RFPs and bid defense meetings.
• Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Recruitment Materials, CRF Completion Guidelines etc.).
• Participates in the development, review and implementation of departmental SOPs and processes.
• Develop and implement operational strategy for assigned clinical trials including country selection, site selection, vendor selection, study timelines and study budget.
• Provide input on study strategy development, protocol, informed consent form, CRF development, and clinical study report preparation.
• Prepares metrics and updates for management, as assigned.
• Ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budget.
• Responsible for identifying, selecting, and closing out appropriate investigational sites for clinical studies.
• Manage all components of clinical trials from protocol inception through CSR completion including site selection, designing CRFs, review of data management plans, ICF development and review, monitoring plans and protocol specific procedures.
• Identify program risks and develop and implement mitigation strategies for assigned programs.
• Negotiate clinical outsourcing vendor agreements including CRO, Central lab, ECG, Imaging vendors as well as manage vendors with respect to contracted scope of work, change orders and budget.
• Provide oversight of site management through review of CRO monitoring visit reports and Key Performance Indicators including quarterly financial reviews of study budgets.
• Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution.

Requirements

• BS/MS degree (science based) is required in a scientific or healthcare discipline, experience in neurodegeneration clinical trials (Alzheimer, Parkinson’s, ALS) or rare disease clinical trials preferred
• 5 years of clinical and drug development experience, to include 3 years of clinical trial management experience
• Start-up biotech experience and hands on experience with early phase studies (Phase 1 & 2) would be beneficial
• Working knowledge of FDA regulations and ICH GCP guidelines is required
• Proven ability to implement and manage a clinical program
• Strong analytical and strategic agility skills
• Highly effective team player with exceptional interpersonal skills
• Ability to travel up to 20% of time
• Willing to travel domestically and internationally

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