Summary 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.
Your role- 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.
What You Bring- 8+ years of trial management experience with 3+ years in trial leadership position.Bachelor's degree in Life Sciences, Pharmacy or related field (required).
- Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred).
- Experience working in global clinical development organization.
- Experience in Oncology development (preferred).
- Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
- Experience in outsourcing and oversight.
- Knowledge of ICH GCP, FDA guidelines, EU CTR and other relevant guidelines.
- Knowledge of financial planning, tracking, and reporting.
- Knowledge of trial risk assessment and management.
- Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs.
- Strong vendor management and project management skills.
- Excellent leadership skills with the ability to lead cross-functional teams.
- Strong interpersonal and communication skills.
- Strong analytical thinking and decision-making capabilities.
- Willingness to travel, as required (typically 10-20%)
#LI-Hybrid
Salary range
$160,000-$241,000 USD
