Clinical Trial Leader
Behavioral Health Market Context
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Qualifications
- •8+ years of trial management experience with 3+ years in trial leadership position
- •Bachelor's degree in Life Sciences, Pharmacy or related field (required)
- •Experience working in global clinical development organization
- •Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl
- •1 more items(s)
Responsibilities
- •We are seeking a Clinical Trial Leader (CTL) to lead cross-functional clinical trial teams (CTTs) in the execution of clinical trials of Tango's portfolio
- •This role will chair the CTT and represent the cross-functional team to internal governance bodies
- •The CTL will be an internal escalation point for other CTT members
- •In a fast-paced, small biotech environment, the CTL will operationally lead the set-up, conduct and reporting of clinical trials as per approved timelines, budget, regulatory requirements, and internal standards
- •This individual will play a key role in the execution and delivery of clinical trial objectives
- •The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution
- •Lead cross-functional Clinical Trial Team (CTT) in the planning, execution, and reporting of outsourced clinical trial
- •Provide regular updates to internal governance bodies
- •Serve as the primary liaison between the sponsor and CRO to ensure alignment of trial objectives, timelines, and deliverables
- •Oversee CRO performance, ensuring adherence to scope, budget, and timelines
- •Contribute to protocol development and review of key study documents (e.g., ICFs, CRFs, monitoring plans)
- •Lead the development of trial-specific plans including risk management, communication, and oversight plans
- •Support site selection and feasibility assessments in collaboration with CRO and internal stakeholders
- •Monitor trial progress through metrics and KPIs
- •In collaboration with Operational Excellence and Compliance, define an optimal RBQM framework to efficiently control quality throughout the trial
- •Proactively identify risks and issues and support the development and implementation of mitigation strategies and action plans
- •Ensure timely delivery of trial milestones including patient recruitment, data collection, and interim analyses
- •Manage trial budgets, change orders, and invoice reconciliation in collaboration with vendor management and finance
- •Ensure study conduct in compliance with ICH GCP, ISO standards, regulatory requirements, and internal standards
- •Participate in audits and inspections
- •Ensure timely resolution of findings
- •Review and approve essential documents and study deliverables
- •Oversee database lock, clinical study report (CSR) development, and study close-out activities
- •Contribute to regulatory submissions and responses as needed
- •21 more items(s)
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