Role Overview
As the Associate Start Up Lead, you will drive the initiation of clinical trial sites within assigned countries, focusing on efficient and compliant activation. Your primary responsibility is to develop and implement site start-up strategies that align with study timelines, ensuring all regulatory, ethical, and contractual requirements are met promptly.
Key Responsibilities
- Develop and manage activation readiness plans to support timely site initiation across designated regions.
- Lead the planning of critical path activities, including ethics committee submissions, regulatory approvals, informed consent form customization, and contract execution.
- Coordinate translation of essential documents and maintain oversight of submission timelines and requirements.
- Collaborate with internal teams such as Regulatory, Clinical Operations, Feasibility, and Contracts to ensure alignment on deliverables and milestones.
- Act as a subject matter expert for local start-up processes, providing guidance on country-specific regulations and internal procedures.
- Track and report progress metrics at study, country, and site levels, ensuring data accuracy and real-time updates in tracking systems.
- Support client-facing activities, including presentations, proposal development, and expectation setting around start-up timelines and risk management.
- Identify potential delays and work proactively with stakeholders to implement mitigation strategies.
- Contribute to training initiatives that enhance team knowledge of country start-up workflows and best practices.
- May provide direct support to site-level start-up tasks or mentor junior staff in regulatory and procedural standards.
Qualifications
Applicants should hold a bachelor’s degree in life sciences or a related field, or be a Registered Nurse with relevant experience. A minimum of three years in clinical trial start-up within a CRO or biopharmaceutical setting is required, including experience in milestone planning, client communication, and cross-functional coordination.
One year of experience managing project timelines, resources, and budgets is essential, along with demonstrated ability to present to clients and use electronic tracking tools. Fluency in English is mandatory; proficiency in the local language of the based country is required for non-English speaking locations.
An advanced degree in life sciences is preferred but not required.
Work Environment
This position supports remote work and is available to candidates based in Serbia, Romania, Hungary, Slovakia, or Poland. The role demands strong organizational skills, attention to detail, and the ability to work independently under tight deadlines.
Technical proficiency with electronic spreadsheets, word processing, email, and milestone tracking systems is expected. The ideal candidate thrives in a collaborative environment and is committed to knowledge sharing and continuous improvement.
