Study Start-up Specialist

• Plan, coordinate, and oversee the start-up process of clinical studies, ensuring deadlines and quality standards are met
• Collaborate with the Regional Submission Lead to deliver start-up milestones on time
• Provide country-specific study start-up expertise and support start-up activities, budget, and contract negotiations
• Review, manage, and translate Informed Consent Forms, adapting study templates to country requirements
• Retrieve essential documents from study sites and perform essential document site file reconciliation
• Conduct independent quality reviews of submission packages and submit packages to EC and HA when required
• Review and translate site-specific recruitment materials and other applicable documents
• Oversee and execute study protocol amendments throughout the study lifecycle
• Ensure inspection readiness of start-up study and site documentation
• Evaluate site practices and escalate quality or GCP issues as appropriate
• Identify site issues, propose corrective and preventative actions, identify gaps, and promote innovation
• Manage and coordinate start-up activities for IVDR studies when required
• Notify HAs of study conclusion and other required milestones
• Act as escalation point for SSUs regarding site-related issues and concerns
• May serve as subject matter expert for clinical operations, country regulations, and SSU-related activities

• Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or a related field (exceptions might be made for candidates with relevant clinical operations experience)
• Minimum of 2 years of experience in the pharmaceutical industry, preferably in startup role
• Solid understanding of regulatory processes and compliance in clinical research
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
• Thorough knowledge of ICH and associated regulatory guidelines
• At least 2 years of Start-up experience in the pharmaceutical or CRO industry
• Fluent in English, Spanish, and Portuguese (writing and speaking)
• Experience working with Portugal is preferred

• Equal opportunity employer
• Travel might be required as per business need