Job Description
**Clinical Study Lead** This role oversees the global execution of clinical trials from study design to close out, ensuring compliance with ICH/GCP and company SOPs. Operate with high independence, accountable for study timelines, budget, and conduct. Responsible for leading cross-functional study teams, providing operational input into protocol development, and overseeing study-specific documentation. Key responsibilities: * Lead cross-functional study teams and serve as primary point of contact for leadership and oversight. * Provide operational input into protocol development and oversee study-specific documentation, including case report forms, data management plans, and monitoring plans. * Ensure compliance with clinical trial registry requirements and oversee set-up and maintenance of study systems. * Identify outsourcing needs and lead engagement, contracting, and management of required vendors. * Provide input into baseline budget development and management and lead risk assessment and mitigation strategies. * Oversee site evaluation and selection, investigator meeting preparation and execution, and monitor progress for site activation and monitoring visits. * Lead the development of and oversee implementation of patient recruitment and retention strategies and monitor data entry and query resolution. * Ensure accurate budget management and scope changes for internal and external studies and oversee study drug and clinical supplies forecasting, drug accountability, and drug reconciliation. * Escalate issues related to study conduct, quality, timelines, or budget to stakeholders and develop and implement appropriate actions. * Oversee the execution of clinical studies against planned timelines, deliverables, and budget. * Ensure data quality and oversee CROs and third-party vendors to ensure they are in alignment and delivering per the scope of work. * Ensure clinical project audit and inspection readiness through the study lifecycle and support internal audit and external inspection activities. * Manage and oversee study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability. * Contribute to clinical study report writing and review and facilitate and contribute to study level lessons learned. **Requirements** * Bachelor's degree with a minimum of 8 years of relevant industry experience. * Advanced degrees may be considered in lieu of relevant experience. * Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. * Technical proficiency in trial management software and MS applications. * Strong budget management experience and advanced project management skills. * Cross-functional team leadership and organizational skills. * Line management experience. * Knowledge of ICH/GCP and regulatory guidelines/directives. * Ability to build, lead, and develop productive study teams and collaborations. * Advanced negotiation and interpersonal skills to vendor management. * Proactive and self-disciplined, with ability to meet deadlines, effective use of time, and prioritization. * Strong leadership and interpersonal skills, with ability to influence and negotiate across a wide range of stakeholders. * Ability to work in a fast-paced environment and adapt to changing priorities and deadlines.