Senior Clinical Operations Manager

Role Description

The Senior Clinical Operations Manager leads clinical operations activities for Junipr Research across clinical trials and 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, vendor 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 in the execution of clinical research activities.
• 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.

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 GDPR platform, eTMF, 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, cooperating with medical writers where required.
• Provide scientific input to support regulatory interactions and submissions.
• Oversee the monitoring and analysis of clinical data to ensure data integrity and adherence to ISO 14155, ICH-GCP, and applicable study requirements

Budget, vendor, and contract management

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

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 junior CTAs and CRAs, 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.

Freelance network and external relationships

• Develop and maintain a pool of freelance clinical research professionals across the EU, including CTAs, CRAs, CPMs, data managers, and statisticians.
• Identify, engage, and manage relationships with key opinion leaders, investigators, vendors, consultants, and other external partners to support clinical development and scientific initiatives.

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

• 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 vendors.
• 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 clinical trial budgets, bidding processes, contracts, and vendor 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 the EU or able to work effectively with EU-based teams, vendors, and freelance professionals.
• Bachelor’s degree in life sciences, biomedical sciences, nursing, pharmacy, public health, or a related field, or equivalent experience.
• Initial experience or strong interest in clinical research or clinical trials.
• Familiarity with clinical research terminology and processes; GCP knowledge is an advantage.
• Strong organisational skills and attention to detail.
• Ability to manage multiple tasks and priorities in a structured manner.
• Good written and verbal communication skills.
• Proficiency in English; knowledge of French and/or Dutch is an advantage.
• Willingness to work on-site in Brussels at least two days per week.

Why join Junipr Research?

• Join a growing Clinical Research Organization (CRO) with a practical, quality-driven, and service-oriented approach to clinical research.
• Take a senior role in shaping clinical operations processes, systems, and delivery models.
• Work across clinical operations, quality, scientific strategy, vendor management, and team development.
• Contribute directly to the development of efficient, compliant, and high-quality clinical research services.
• Collaborate with experienced professionals, external experts, and a growing EU-based freelance network.
• Help build a clinical operations function that supports meaningful research and strong study execution.