Study Start-up Specialist

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

📋 Description

• Oversee study start-up activities in the Netherlands, offering local expertise.

• Identify deficiencies and improvement opportunities, while proposing CAPA.

• Collaborate with the Regional Clinical Operations Manager/Start-up Lead to meet study timelines and uphold quality standards.

• Provide country-specific expertise for study start-up and assist with associated activities.

• Aid in budget and contract negotiations.

• Gather essential documents from study sites and conduct essential document site file reconciliations.

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

• Review and translate drug labels, informed consent forms (ICFs), site-specific recruitment materials, and other relevant documents.

• Manage sites and assess site performance by tracking regulatory submissions and related milestones.

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

• Work alongside the Regional Clinical Operations Manager/Start-up Lead and clinical study sites to achieve start-up milestones punctually.

• Assess the quality and integrity of site practices and escalate any quality or GCP concerns as necessary.

• Proactively identify site issues, recommend corrective and preventative actions, pinpoint gaps, and seize opportunities.

• Aim for operational excellence, challenge existing norms, and foster innovation.

⛳️ Requirements

• Bachelor’s degree in a relevant scientific field.

• 1–2 years of experience in start-up activities.

• Preferred experience in oncology global trials.

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

• Comprehensive understanding of clinical trial processes.

• In-depth knowledge of ICH and related regulatory guidelines.

• 1–2 years of start-up experience within the pharmaceutical or CRO industry.

• Exceptional communication and interpersonal skills.

• Strong organizational skills with the ability to prioritize and multitask effectively.

• Fluent in both English and Dutch, in written and spoken forms.

🏝️ Benefits

• Opportunity for remote work in Denmark.

• Travel commitments of up to 15%.