Study Start-up Specialist

This is a fully remote position, open to applicants in Spain.

📋 Description

• Develop, coordinate, and manage the initiation process of clinical studies, ensuring that deadlines and quality benchmarks are achieved.

• Collaborate with the Regional Submission Lead to ensure the timely delivery of start-up milestones.

• Offer country-specific expertise for study initiation and assist with start-up activities, including budget and contract negotiations.

• Review, manage, and translate Informed Consent Forms, customizing study templates to meet local requirements.

• Gather essential documents from study sites and perform reconciliation of essential document site files.

• Conduct independent quality assessments of submission packages and submit them to the EC and HA as necessary.

• Review and translate site-specific recruitment materials and other relevant documents.

• Oversee and implement amendments to study protocols throughout the study's lifecycle.

• Ensure that start-up study and site documentation is inspection-ready.

• Assess site practices and escalate quality or GCP concerns as needed.

• Identify site-related issues, suggest corrective and preventative measures, pinpoint gaps, and foster innovation.

• Manage and coordinate start-up activities for IVDR studies when necessary.

• Inform HAs of study completion and other important milestones.

• Act as the point of escalation for SSUs regarding issues and concerns related to sites.

• May function as a subject matter expert in clinical operations, country regulations, and SSU-related tasks.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or a similar field (candidates with relevant clinical operations experience may be considered).

• A minimum of 2 years' experience in the pharmaceutical industry, ideally in a start-up role.

• Strong understanding of regulatory processes and compliance in clinical research.

• Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Comprehensive knowledge of ICH and related regulatory guidelines.

• At least 2 years of experience in start-up operations within the pharmaceutical or CRO industry.

• Fluent in English, Spanish, and Portuguese (both written and spoken).

• Experience working in Portugal is preferred.

🏝️ Benefits

• Equal opportunity employer.

• Travel may be required based on business needs.