Study Start-Up Lead

This is a fully remote position, open to applicants in Spain, +3 more states.

📋 Description

• Provide SSU insights for the trial Operational Execution Plan and ensure alignment of the SSU plan and strategy with the Study Leader/Clinical Trial Team.

• Set up and maintain trial-specific configurations for SSU systems, including eTMF, CTMS, milestones, tasks, vendors, translations, countries, enrollment, contracting, budgeting, and ICF tools.

• Lead global SSU planning and guide the SSU Team from the kickoff through to the completion of study start-up.

• Ensure the timely collection and filing of global trial-level documents in eTMF for submissions to health authorities and Ethics Committees as well as site activation.

• Assist the Vendor Program Manager with global vendor activation and the preparation of health authority submission documents.

• Prepare global Protocol and ICF templates for use in various countries, including necessary translations.

• Oversee investigator grant planning, fair-market-value evaluations, and the readiness of country site budget and contract templates.

• Maintain overall accountability for study start-up TMF timelines, accuracy, quality, and readiness for inspections.

⛳️ Requirements

• Must possess the right to work in the UK, Spain, Poland, or Bulgaria.

• Relevant experience in a similar position, preferably in a senior SSU role.

• Experience in the Clinical Research, Biotech, or Pharmaceutical industries is essential.

• Ability to commence a new role within 4–8 weeks is highly preferred.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.