Study Start-Up Lead

Job Description

Job Summary:

• This role focuses on the efficient and compliant initiation of client-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.
• You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff.
• Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

Duties and Responsibilities:

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
• Ensuring alignment with global strategies and timelines.
• Managing amendments throughout the study lifecycle.
• Identifying and driving opportunities for process automation, standardization, and innovation.
• Collaborating with regional and global counterparts to harmonize systems and improve timelines.
• Participating in external industry collaborations to influence country start-up environments.
• Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).

You will lead in a cross functional environment in multiple of the following areas below:

Study Start-Up Strategy & Execution:

• Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.

Informed Consent Form (ICF) Management:

• Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices.

Clinical Trial Submissions & Regulatory Coordination:

• Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.

Site Documentation & Compliance:

• Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.
• Oversee translation and approval of drug labels and patient-facing materials, as required.
• Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs.

Budgeting & Contract Management:

• Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting.
• Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

Qualifications:

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.
• Postgraduate degree or master’s degree highly desirable.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Experience managing vendor/CRO relationships.
• Proven leadership or line management experience (for PLs) Skills & Competencies.
• Excellent communication and interpersonal skills.
• Strong organizational, analytical, and problem-solving capabilities.
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).
• Collaborative and adaptable mindset with attention to detail.
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams.
• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language(s) of the host country is mandatory.