Clinical Digital Transformation & Compliance Manager

Role Description (full-time / part-time)

Junipr Research is a specialised service provider offering expert consulting to life science companies. We are looking for a motivated and detail-oriented Clinical Digital Transformation & Compliance Manager to support and shape the implementation of innovative, digital-first stakeholder engagement and clinical compliance services.

This role combines clinical operations and compliance expertise with a strong interest in digitalisation, AI-enabled tools, and continuous improvement. You will support both Junipr Research’s internal operations and its client-facing services, helping to translate regulatory and quality requirements into practical, scalable, and user-friendly processes.

We are seeking a professional with a background in clinical research, quality, or regulatory compliance, who is curious about how digital and AI-enabled solutions can improve efficiency, consistency, and audit-readiness. In this position, you will play a hands-on role in shaping Junipr Research’s hybrid service model, embedding automation into clinical and operational workflows, and supporting alignment with international regulatory requirements, while working closely with a small team and external experts.

Responsibilities

Clinical Digitalisation & Innovation

• Take strategic ownership of Junipr Research’s digitalisation trajectory, ensuring automation, AI-enabled solutions, and compliance-by-design are integrated across all service lines.
• Lead the development and implementation of digital clinical systems and workflows (e.g. Atlassian-based tools such as Jira and Confluence, GDPR workflows, QMS tooling, and reporting dashboards).
• Design and oversee automated and semi-automated workflows for documentation, multilingual content, compliance tracking (e.g. RoPAs, DPIAs), and internal reporting.
• Drive internal adoption of digital and AI-supported ways of working, acting as a hands-on enabler for the team.
• Collaborate with the external Strategic Consultant/DPO to ensure digital systems align with GDPR, cybersecurity expectations, and evolving international regulatory frameworks (e.g. MDR, CTR, FDA, MHRA).
• Contribute to Junipr Research’s transition to a hybrid revenue model by supporting the operational and compliance foundations for scalable, potentially licensed, tool-enabled services, without being solely responsible for product development.
• Actively explore, test, and apply AI-enabled tools and digital solutions to improve efficiency, quality, and consistency of compliance, documentation, and operational workflows.
• Support the compliant use of digital communication and social media tools within patient and stakeholder engagement programmes, ensuring appropriate governance, documentation, and alignment with regulatory, privacy, and ethical requirements.

Clinical Operations & Quality Management

• Support the development, implementation, and maintenance of clinical operations and quality processes, ensuring they are pragmatic, proportionate, and audit-ready.
• Develop, maintain, and continuously improve procedures, policies, templates, and quality standards, including QMS and GDPR-related documentation.
• Act as an operational and quality point of contact, ensuring processes are followed, documented, and improved where needed.
• Maintain an overview of Junipr Research’s compliance posture and operational risks, escalating issues when needed and supporting continuous improvement and inspection readiness.
• Support collaboration with external partners (e.g. auditors, consultants, DPO) from an operational and quality perspective.
• Take responsibility for day-to-day operational support in a small team environment, including IT onboarding, system access coordination, and general operational continuity.
• Support internal training and knowledge-sharing related to clinical operations, quality, compliance, digital tools, and AI-enabled working methods.
• Optional, depending on experience and interest: support clinical studies in a project management and/or clinical affairs role.

Qualifications

• Bachelor’s or Master’s degree in a life sciences, health sciences, or related field.
• Experience or strong interest in clinical operations, clinical affairs, quality, or programme/project coordination, with exposure to regulatory and stakeholder environments.
• Strong familiarity with digital clinical systems (e.g. Atlassian Jira, Atlassian Confluence, CTMS, EDC, eTMF) or the motivation to quickly learn and apply new digital tools to improve efficiency and compliance.
• Demonstrated interest in digitalisation and AI-enabled tools, and curiosity to explore how technology can improve compliance, documentation quality, and operational workflows.
• Interest in or basic familiarity with digital communication channels (including social media) in a regulated life sciences context, with an understanding of the importance of governance, compliance, and patient protection.
• Knowledge of data protection and privacy requirements (e.g. GDPR), with the ability to translate compliance principles into practical, day-to-day workflows.
• Working knowledge of GCP, ICH guidelines, and relevant international regulatory frameworks (e.g. MDR, CTR, FDA, UK MHRA/HRA), or willingness to further develop expertise.
• Strong analytical and problem-solving skills, with the ability to work with complex regulatory, operational, and scientific information.
• Strong collaboration, coordination, and ownership mindset, with the ability to support colleagues and take responsibility in a small, fast-moving team.
• Excellent communication and interpersonal skills, with the ability to explain compliance, quality, and digital topics clearly to different audiences.
• Fluent in English; knowledge of Dutch and/or French is an advantage.
• Willingness to travel occasionally, if required.

Why join JunipR Research?

JunipR is a growing company that works exclusively with highly talented people who value scientific excellence, quality, respect, and initiative.

At JunipR, you will:

• Play a key role in supporting and developing our clinical services.
• Gain experience across diverse clinical studies and therapeutic areas.
• Learn best practices in clinical operations, monitoring, and patient involvement.
• Grow quickly through hands-on learning and mentorship.
• Contribute to a positive and respectful experience for patients, sites, healthcare professionals, and sponsors.
• Work in a supportive, collaborative team that values knowledge sharing.
• Benefit from a flexible Work From Home policy.
• Grow professionally and personally in an environment that values integrity, scientific curiosity, ownership, and continuous learning.