Clinical Start-Up Specialist

Location: Athens (office based)

Your New Role

The Study Start-Up Specialist is responsible for the end-to-end execution of clinical trial start-up activities and regulatory submissions at country and site level. The role ensures timely study activation regulatory compliance and delivery of key start-up milestones through effective collaboration with internal teams investigators Ethics Committees Health Authorities and external partners.

The role requires professionals with:

• Strong knowledge of clinical trial regulations submission requirements and ICH-GCP.
• Experience managing clinical trial submissions and study start-up activities.
• Digital & AI curiosity proficiency with clinical trial management systems eTMF platforms.
• Strong project management planning organizational and prioritization skills.
• Excellent analytical thinking problem-solving ability and attention to detail.
• Effective communication and stakeholder management skills.
• Ability to work independently manage multiple priorities and deliver high-quality work in a fast-paced clinical research environment.

This is a 100% office-based role (Athens).

Key Responsibilities

1. Study Start-up & Submission Execution

• Lead coordinate and manage execution of start-up activities for assigned trials. Oversee the full set of start-up tasks at country and site level and monitor completion against milestones.
• Lead coordinate and manage the preparation review and submission of documents following local and EU CTR submission procedures and ensure dossier completeness and accuracy.
• Use Authority (HA) and/or Ethics Committee (EC) dossiers ensuring compliance with ICH GCP regulations local requirements and Novo Nordisk processes.
• Co-develop regulatory strategy and SSU plans for assigned trials with TMs and SSU Manager in alignment with CDC strategy and industry best practice. Collaborate with TMs and leadership to define timelines submission approaches and country-specific considerations.
• Perform Quality Control (QC) and upload documents to eTMF ensuring regulatory milestones and timelines are met at country and site levels.
• Customize translate and/or prepare key documents such as Informed Consent Forms (ICFs) patient materials Labels and Clinical Trial Application (CTA) documents at country and site levels including updates requested by EC and/or HA. Adapt standard documents to local language legal and cultural requirements while preserving regulatory and protocol content.
• Perform and coordinate core label reviews in collaboration with Regulatory Clinical and Quality teams to ensure labels meet protocol and regulatory requirements.
• Record and maintain study information in local/national registries.
• Execute site activation activities including Green Light readiness coordination of supplies and equipment delivery collection of essential documents and preparation of drug release documentation.
• Ensure the assignment and execution of site staff training as per training plan.
• Identify and share potential risks on the site level and proactively take action to prevent or mitigate. Escalate unresolved issues to management.
• Plan and track regulatory milestones in CTMS at country and site levels.

2. Productivity Oversight

• Provide local regulatory insights and intelligence to trial teams and Global/Regional stakeholders. Share with TM and Therapeutic areas country-specific regulatory interpretations timelines and submission considerations to aid planning.
• Support continuous improvement and innovation initiatives related to SSU compliance and regulatory submissions processes. Participate in projects suggest improvements and help implement new ways of working or tools.

3. Stakeholder Engagement & Communication

• Liaise with cross-functional teams to ensure alignment and timely delivery of start-up and submission activities.
• Participate in kick-off meetings with trial start-up team provide input to submission site identification and selection and local start-up timelines and monitor and communicate critical issues that may impair trial progress. Contribute to country-level feasibility input as well as timeline estimates and highlight potential barriers to site activation.
• Build and maintain excellent relationships with clinical sites Ethics Committees and Health Authorities. Foster professional responsive relationships and act as a reliable point of contact for queries and submissions.

4. Quality Oversight

• Ensure start-up and submission activities adhere to ICH GCP regulatory requirements and internal SOPs.
• Contribute to Inspection Readiness and support audits and/or inspections. Prepare documentation and respond to audit requests as needed.
• Proactively identify and escalate study start-up compliance risks or process gaps.

Experience & Education

• Minimum 3 years of experience in clinical research study start-up regulatory affairs or clinical trial submissions.
• Bachelors degree in Life Sciences Pharmacy or a related discipline.
• Advanced degrees or related work experience are considered an advantage.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with an unconventional spirit a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.

• Salary:For this role the Annual Base Salary ranges from 41340.00 y 67380.00 EUR corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidates skills competencies knowledge and relevant experience.
• Incentives and Benefits:The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level location functional area and relevant market benchmarks.

Learn more about our Reward Philosophyhere.

Deadline

Apply before30 August. Applications are reviewed on an ongoing basis. To submit your application please upload your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.