Study Start-up Specialist

• 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 researc

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• At least 2 years of Start-up experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Fluent in English, Spanish, and Portuguese (writing and speaking)
• Experience working with Portugal is a preferred.

Travel: Travel might be required as per business need

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

General Description

The Startup Specialist will be responsible for managing and coordinating all activities related to the startup of clinical trials at multiple sites.

This role is crucial to ensure that trials are initiated efficiently and meet regulatory and quality requirements.

• Plan, coordinate, and oversee the start-up process of clinical studies, ensuring that deadlines are met, and quality standards are upheld. Collaborate with the Regional Submission Lead to ensure the timely delivery of start-up milestones.
• Provide country-specific study start-up expertise, assist in start-up activities, and provide support in budget and contract negotiations
• Review, manage, and translate the Informed Consent Form, adapting the Study template to Country requirements.
• Work closely with investigators, physicians, and other research team members to retrieve essential documents from study sites and perform essential document site file reconciliation
• Perform independent quality review of submission packages, submit package to EC (and HA), if required,
• Review and translate site-specific recruitment materials and other applicable documents.
• Oversee and execute amendments to study protocols during the lifecycle of the study, ensuring timely communication and compliance with regulatory requirements.
• Ensure inspection readiness of start-up study and site documentation.
• Evaluates the quality and integrity of site practices - escalating quality and/or GCP issues with Investigators and internal team as appropriate.
• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question the status quo, and promote innovation.
• Manage and coordinate the startup activities specific to In Vitro Diagnostic Regulation (IVDR) studies, ensuring compliance with relevant regulations and standards, if required.
• Notify HAs of the study's conclusion and other required milestones as mandated.
• Acts as the escalation point person for SSUS(s) with site related issues and concerns.
• May serve as subject matter expert for clinical operations, country regulations and SSU-related activities