Clinical Trial Manager

Maclivaro Limited; Lausanne; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Confidential in Lausanne seeks a Clinical Study Manager to lead planning, coordination and execution of clinical performance and validation studies for IVDs in oncology. You will work with senior clinical, regulatory and technical stakeholders to ensure timely delivery and adherence to quality and regulatory standards.

In this hands-on, fast-moving role you’ll own clinical programmes across development areas, build processes, and interact with investigators and sites to advance novel diagnostic

Qualifikationen

• Experience designing and coordinating clinical performance/validation studies.
• Knowledge of regulatory requirements for IVD/medical devices.
• Ability to work across clinical/scientific/technical stakeholders.

Aufgaben

• Plan, coordinate and execute clinical performance and validation studies.
• Coordinate sites, investigators, hospitals and CROs.
• Develop study protocols, timelines and documentation.
• Support regulatory submissions and evidence generation.
• Maintain trial documentation and records with quality standards.
• Provide updates to leadership on progress, risks and issues.

Kenntnisse

Clinical studies

IVD experience

Oncology

Regulatory knowledge

Project management

Stakeholder coordination

Documentation

Quality systems

Ausbildung

Master's degree in Life Sciences

Cert. in Clinical Research

Tools

CTMS

eTMF

Jobbeschreibung

Clinical Study Manager | IVD | Oncology | Lausanne, Switzerland

Sector: Medical Diagnostics / Life Sciences

Level: Clinical Study Management

Company: Confidential, early-stage startup

I'm currently working on a confidential search for a Clinical Study Manager to join an exciting, early-stage healthcare technology startup based in Lausanne, Switzerland.

The company is developing innovative diagnostic technologies within the oncology space, with the ambition of improving clinical decision-making and supporting more personalised approaches to patient care.

This is a fantastic opportunity for a clinical research professional who wants to move beyond simply managing studies within a large corporate environment and instead have the opportunity to take real ownership of clinical programmes and see their work directly contribute to the development of an innovative technology.

The Opportunity

As Clinical Study Manager, you will play a key role in the planning, coordination and execution of clinical performance and clinical validation studies.

Working closely with senior clinical, scientific, regulatory and technical stakeholders, you will help ensure studies are delivered on time, to a high standard and in accordance with applicable regulatory and quality requirements.

Because this is an early-stage business, you'll have the opportunity to work across multiple areas of clinical development and make a meaningful contribution to building the company's clinical infrastructure.

Key responsibilities

• Support the planning, set-up and execution of clinical performance and clinical validation studies for IVDs.
• Coordinate clinical studies across hospitals, laboratories, clinical sites and external partners.
• Support the development of study protocols, documentation, timelines and operational plans.
• Coordinate communication with investigators, clinical sites, CROs and other study partners.
• Track study milestones, deliverables, risks and actions.
• Support site identification, selection, qualification and initiation.
• Monitor study progress and help resolve operational issues and delays.
• Maintain accurate clinical study documentation and records.
• Support preparation for regulatory submissions and ensure clinical documentation is maintained appropriately.
• Work closely with Quality and Regulatory colleagues to ensure studies are conducted in accordance with applicable requirements.
• Support clinical data collection, review and reporting activities.
• Contribute to clinical study reports, publications and scientific communications.
• Help establish and improve clinical study processes and systems as the company grows.
• Provide clear updates on study progress, risks and issues to senior leadership.

About you

We're looking for someone with solid clinical research experience who is comfortable working in a hands-on, fast-moving environment.

You’ll ideally have:

• Experience managing or coordinating clinical studies, ideally within IVDs, diagnostics, medical devices or a related regulated environment.
• Experience working with clinical sites, investigators, hospitals and/or CROs.
• A good understanding of clinical study methodology, documentation and regulatory requirements.
• Experience supporting clinical performance or validation studies would be highly advantageous.
• Ideally, exposure to oncology, biomarkers, personalised medicine or molecular diagnostics.
• Familiarity with IVDR / CE-IVDR requirements would be highly desirable.
• Strong organisational and project-management skills.
• Excellent attention to detail and the ability to manage multiple priorities simultaneously.
• Strong written and verbal communication skills.
• The confidence to work independently and proactively rather than waiting for instructions.
• A genuine interest in working within an early-stage startup environment.

This isn't a role where you'll be one small part of a large clinical operations machine.

You'll be joining an early-stage company at an important point in its development, giving you the opportunity to:

• Work directly on innovative oncology diagnostic technology.
• Take meaningful ownership of clinical studies from planning through execution.
• Build relationships with investigators, hospitals and clinical partners.
• Gain valuable exposure to IVDR, clinical evidence generation and regulatory strategy.
• Help build clinical processes and infrastructure as the company scales.
• Work closely with experienced scientific, medical and technical colleagues.
• Develop your career within a growing biotech/diagnostics startup.
• See your work contribute directly to the clinical and scientific credibility of a technology with the potential to make a meaningful difference to patient care.

This is a confidential appointment. Further information about the organisation, technology and development plans will be shared with shortlisted candidates.

This could be an excellent opportunity for someone looking to take the next step in their clinical career while joining a company where they can genuinely make an impact.