Clinical Trial Start-Up Lead

Benefits

Qualifications

• •Experience in clinical trial start-up, regulatory submissions, and clinical operations
• •Strong understanding of ICH-GCP and regulatory frameworks
• •Experience managing vendors/CROs and cross-functional teams
• •Excellent communication and stakeholder management skills
• •Strong analytical, organizational, and problem-solving abilities
• •Experience with clinical systems (e.g., Veeva Vault, CTIS, RIM)
• •Ability to work in complex, global, matrix environments
• •Fluent in English (additional local language proficiency required)
• •5 more items(s)

Responsibilities

• •This position focuses on enabling timely study initiation, improving processes, and ensuring seamless collaboration across global, regional, and local stakeholders
• •Study Start-Up Strategy & Execution
• •Lead country-level study start-up strategies to ensure efficient and timely trial initiation
• •Oversee execution of start-up activities, including risk mitigation and regulatory compliance
• •Align country activities with global timelines and strategies
• •Regulatory & Submission Management
• •Manage clinical trial submissions, amendments, and regulatory coordination
• •Ensure accurate documentation, timely responses to regulatory queries, and lifecycle support
• •Informed Consent Form (ICF) Oversight
• •Lead preparation, submission, and archiving of ICFs
• •Ensure compliance with corporate standards and regulatory requirements
• •Site Activation & Compliance
• •Oversee site documentation, validation, and compliance processes
• •Manage local vendors (non-CRO) and ensure readiness for site activation
• •Maintain knowledge of country-specific regulations and requirements
• •Budgeting & Contract Management
• •Develop and manage site budgets based on Fair Market Value principles
• •Lead contract negotiations, including CDAs, indemnity, and insurance documentation
• •Ensure accurate contract tracking and forecasting
• •Financial Oversight
• •Monitor payment processes, reporting, and reconciliation
• •Ensure compliance with financial and regulatory requirements
• •Process Improvement & Collaboration
• •Identify opportunities for automation, standardization, and innovation
• •Collaborate with global teams and CROs to improve timelines and efficiencies
• •Engage with regulatory authorities, ethics committees, and external stakeholders
• •Leadership Responsibilities (if applicable)
• •Provide coaching, mentorship, and performance management to team members
• •Foster an inclusive and collaborative team environment xrczosw
• •Support employee development and address performance or operational challenges
• •27 more items(s)