Clinical Research Manager

SkylineDx BV is an innovative molecular diagnostics company dedicated to improving patient outcomes through precision medicine. By developing and commercialising genomic tests that support clinical decision-making, SkylineDx partners with healthcare professionals, researchers, and industry leaders to advance personalised healthcare and transform patient care worldwide.

Position Summary

SkylineDx BV is seeking an experienced and motivated Clinical Research Manager to lead the planning, execution, and oversight of clinical research programmes supporting the development, validation, and commercialisation of molecular diagnostic products. The successful candidate will manage clinical studies from conception through completion, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company quality standards while collaborating with cross-functional teams to deliver high-quality clinical evidence.

Key Responsibilities

• Lead the planning, implementation, and management of clinical research studies supporting molecular diagnostic and precision medicine products.
• Develop study plans, timelines, budgets, and resource allocation to ensure successful project delivery.
• Ensure all clinical studies are conducted in compliance with ICH-GCP guidelines, applicable regulatory requirements, and company Standard Operating Procedures (SOPs).
• Coordinate study start-up activities, including site selection, ethics submissions, contracts, and investigator meetings.
• Manage relationships with investigators, clinical sites, Contract Research Organisations (CROs), laboratories, and external vendors.
• Monitor study progress, identify risks, and implement mitigation strategies to maintain timelines and study quality.
• Oversee data quality, study documentation, monitoring activities, and clinical trial master files.
• Collaborate with Regulatory Affairs, Medical Affairs, Quality Assurance, Biostatistics, Biomarker, Product Development, and Commercial teams.
• Support regulatory submissions by providing clinical documentation and study reports.
• Prepare clinical study updates, metrics, and presentations for senior leadership and external stakeholders.
• Ensure inspection and audit readiness throughout the clinical study lifecycle.
• Lead, mentor, and support Clinical Research Associates, Clinical Trial Coordinators, and project team members where applicable.
• Drive continuous process improvements to enhance operational efficiency and study quality.

Required Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Nursing, Biotechnology, or a related discipline.
• Master's degree is desirable.
• Minimum of five years' experience in clinical research, with at least two years managing clinical studies or clinical operations.
• Strong understanding of ICH-GCP, ISO 14155 (where applicable), and global regulatory requirements for clinical research.
• Experience managing multi-site clinical studies, preferably involving molecular diagnostics, oncology, immunology, or precision medicine.
• Proven project management and organisational skills with the ability to manage multiple priorities.
• Experience working with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and Microsoft Office applications.
• Excellent written and verbal communication skills in English.
• Ability to build strong relationships with internal and external stakeholders.

Preferred Qualifications

• Experience within the molecular diagnostics, biotechnology, or in vitro diagnostics (IVD) industry.
• Knowledge of biomarker validation and translational research.
• Certification through ACRP, SOCRA, or equivalent clinical research professional organisation.
• Experience supporting international or multicentre clinical studies.
• Familiarity with IVDR and diagnostic product development processes.

Key Competencies

• Clinical project management
• Leadership and team development
• Strategic thinking
• Regulatory and GCP compliance
• Risk management
• Analytical and problem-solving skills
• Budget and resource management
• Stakeholder engagement
• Attention to detail
• Excellent communication and collaboration skills

What SkylineDx BV Offers

• Opportunity to contribute to cutting-edge precision medicine and molecular diagnostics.
• Collaborative, innovative, and science-driven work environment.
• Professional development and continuous learning opportunities.
• Competitive salary and comprehensive benefits package.
• Flexible working arrangements where business needs permit.
• A diverse and inclusive workplace committed to innovation, quality, and improving patient outcomes.

Equal Opportunity Employer

SkylineDx BV is committed to creating an inclusive workplace where diversity is valued. We welcome applications from all qualified candidates regardless of age, disability, gender identity, marital status, race, religion or belief, sex, sexual orientation, or any other protected characteristic.