As Senior Clinical Operations Manager, you will lead clinical operations activities for Junipr Research across clinical research projects. This role is responsible for overseeing study execution, improving operational processes, advising project teams, mentoring clinical team members, and ensuring that clinical operations are delivered in line with ISO 14155, ICH-GCP, and applicable regulatory requirements. The role combines operational leadership, scientific and clinical input, quality and clinical system development, supplier and budget oversight, people management, and contribution to the continued growth of Junipr Research.

Responsibilities

Clinical operations leadership

- Lead clinical operations activities for Junipr Research across clinical trials, studies, and programs.
- Plan, coordinate, and oversee clinical trial activities to ensure delivery according to agreed scope, timelines, budget, and quality expectations.
- Advise project teams and support Clinical Affairs Managers
- Manage and coordinate cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs.
- Proactively identify, escalate, and address risks to clinical programs, study delivery, and data quality.

People leadership and mentoring

- Act as line manager for CRAs, CTAs, and the freelance clinical research professional pool, providing operational guidance, training, and coaching.
- Onboard and coach new team members, actively developing them into independent clinical research professionals.
- Support team development by identifying training needs, sharing best practices, and contributing to a high-quality clinical operations culture.

Quality systems, SOPs, and clinical systems

- Develop, maintain, and optimize SOPs, templates, and work instructions in line with the most recent versions of ISO 14155 and ICH-GCP.
- Lead the implementation, adoption, and continuous improvement of clinical systems and processes, including our in-house Privacy Information Management System, and Project Management System.
- Drive operational efficiency through improved documentation standards, budgeting practices, and clinical operations workflows

Scientific, clinical,



and regulatory support

- Provide scientific and clinical expertise to align trial design and execution with regulatory requirements, scientific objectives, and study-specific needs.
- Develop and maintain essential study documents, including protocols, investigator brochures, clinical evaluation reports, and regulatory submission documents, in cooperation with medical writers where required.
- Provide input to support regulatory interactions and submissions.
- Oversee the monitoring and analysis of clinical data to ensure data integrity

Budget, supplier, and contract management

- Develop, manage, and optimize clinical study budgets and operational efficiency across projects.
- Lead bidding and contract negotiation with potential clients.
- Oversee supplier selection, management, and performance monitoring to ensure quality, delivery, and adherence to timelines and budgets.

Freelance network and external relationships

- Develop and maintain a pool of freelance clinical research professionals
- Identify, engage, and manage relationships with key opinion leaders, investigators, suppliers, consultants, and other external partners

Business development and growth

- Contribute to business development and expansion activities by identifying new opportunities, services, and operational capabilities, which includes representing the organization through conference attendance.
- Provide operational and scientific input for proposals, client discussions, and service development.

Qualifications and requirements for the role

- Advanced degree in life sciences, clinical research, medicine, biomedical sciences, pharmacy or a related discipline.
- Strong experience in clinical operations, clinical project management, clinical affairs
- In-depth knowledge of ISO 14155, ICH-GCP,



and applicable clinical research regulations and guidance.
- Demonstrated experience leading clinical studies, managing project teams, and overseeing suppliers.
- Experience developing or optimizing SOPs, templates, work instructions, and quality processes.
- Experience with clinical systems such as eTMF, eISF, CTMS, EDC, and other clinical platforms.
- Experience managing budgets, bidding processes, contracts, and supplier performance.
- Strong understanding of essential clinical study documents, regulatory submissions, and clinical data quality requirements.
- Experience mentoring, onboarding, coaching, or line managing clinical research professionals.
- Ability to work effectively with cross-functional teams, external partners, investigators, and key opinion leaders.
- Excellent written and verbal communication skills in English.
- Strong organizational, analytical, and problem-solving skills.
- Based in Belgium.

Why join Junipr Research?

This is a unique opportunity to help shape a growing clinical research organisation while working across a broad and varied range of clinical activities. At Junipr Research, you can:

- Play a key role in building our clinical operations capabilities, processes, and ways of working.
- Enjoy variety in your work, with opportunities to contribute across studies, therapeutic areas, quality, suppliers, and team development.
- Bring your ideas and experience to practical solutions that support clients, study teams, and high-quality clinical research.
- Grow your expertise through meaningful responsibility, close collaboration, and opportunities to learn from experienced professionals and external experts.
- Help shape a supportive, straightforward, and human team culture where initiative and autonomy are valued.
- Benefit from a adaptable work-from-home (WFH) policy.

Interested?

- Please ensure to apply via LinkedIn, upload your CV, and a motivation letter. It's always a nice plus to also include a reference.

- Recruiters, thank you for your interest. At this moment we don't need extra support in the hiring process, so there is no need to reach out to us yet.

📌 Senior manager clinical operations (España)
🏢 Junipr Research
📍 España