Study Start-Up Lead (SSUL) – External Job Description (6 month contract)
Purpose & Role Overview
The Study Start-Up Lead (SSUL) plays a central role in driving efficient and high-quality study start-up activities to support the delivery of clinical trials. This position leads and coordinates the processes that enable timely trial initiation, supporting innovative trial delivery across multiple therapeutic areas. You will work closely with local and global teams, clinical sites, external partners, and vendors to ensure a seamless start-up experience for investigators, site staff, and study participants.
Key Responsibilities
Study Start-Up Strategy & Execution
*Lead the development and execution of country-level study start-up strategies.
*Drive efficiency, innovation, and proactive risk mitigation throughout the start-up process.
*Collaborate with internal stakeholders, global study teams, and CRO partners to ensure alignment with overall study plans and timelines.
*Ensure compliance with regulatory requirements and internal processes.
*Lead knowledge management, tracking, and cross-functional coordination.
Informed Consent Form (ICF) Management
*Oversee the strategic development, preparation, submission, and archiving of ICFs.
*Ensure compliance with corporate standards, ethical guidelines, and best practices.
Regulatory Submissions & Coordination
*Lead preparation and submission of local clinical trial applications and amendments to relevant ethics bodies and regulatory authorities.
*Manage regulatory packages, handle authority queries, and maintain submission documentation throughout the study lifecycle.
Site Documentation & Compliance
*Oversee collection, validation, and maintenance of site documentation in accordance with local regulations and quality standards.
*Support preparation and translation of patient-facing materials.
*Maintain up-to-date knowledge of local requirements for medicinal products, medical devices, and diagnostics.
Site Contracting & Payment Management
*Lead planning, budgeting, and negotiation of clinical site contracts, including confidentiality agreements, indemnities, and amendments.
*Ensure accurate financial and legal alignment across stakeholders.
*Oversee site payment processes, issue resolution, reporting, and financial reconciliation.
Qualifications
*Degree in life sciences (MD, PhD, MSc, or Bachelor’s degree). A postgraduate qualification is advantageous.
*Proven experience in clinical trial start-up, submissions, and regulatory coordination.
*Strong understanding of ICH-GCP, EU Clinical Trial Regulation, and local regulatory frameworks.
*Experience engaging with CROs, vendors, and clinical sites.
*Demonstrated experience leading site start-up through activation.
*Familiarity with commonly used clinical systems (e.g., eTMF, regulatory information systems, clinical trial portals).
Skills & Competencies
*Excellent communication and interpersonal skills.
*Strong organisational abilities with a detail-oriented and solution-driven mindset.
*Analytical thinker with the ability to navigate complexity and ambiguity.
*Proven ability to collaborate effectively in cross-functional, matrixed environments.
*Fluent in English and the primary language(s) of the country of operation.