(Senior / Advanced) Clinical Study Manager

Brainlab

München

Hybrid

EUR 90,000 - 130,000

Full time

4 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

International team with meaningful, up

Hybrid work model within Germany

30 vacation days + holidays

Job summary

Brainlab is seeking a Senior/Advanced Clinical Study Manager in Munich to independently lead clinical studies and medical device investigations from concept to completion. You will ensure high-quality execution, regulatory compliance, and timely delivery of clinical evidence while collaborating with Product Management, R&D, and Clinical Marketing.

The role requires 5+ years of clinical research leadership, deep knowledge of EU MDR, TMF management, and strong project management skills.

Qualifications

5+ years of relevant experience in clinical research, preferably in the medical device industry.
Independent management of clinical studies or investigations.
Strong knowledge of EU MDR (2017/745) and ISO 14155.
Experience with TMF/eTMF management and study budgeting.

Responsibilities

Independently plan, initiate, manage, and close clinical studies and investigations, including multicenter and international studies.
Develop and manage study protocols, timelines, budgets, contracts, site selection, investigator relationships, monitoring, and data management oversight.
Ensure compliance with clinical research regulations, ethical standards, and quality requirements.
Maintain inspection-ready TMF/eTMF and essential study documentation; contribute to SOPs and processes.
Collaborate with Product Management, R&D, Clinical Marketing, Regulatory Affairs to align evidence with product roadmaps.
Proactively manage study risks, external partners, data quality, and progress; communicate milestones to stakeholders.

Skills

Project management

Organizational skills

Communication

Stakeholder management

Education

University degree in life sciences/biomedical engineering/medicine

Job description

(Senior / Advanced) Clinical Study Manager

Full-time
Department: R&D Software

At the forefront of health technology for over 35 years, Munich-based Brainlabdigitizesmedical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.

Our key to success is our creative,talentedand hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious,authenticand useful.

We are looking for an experienced, proactive, and self-driven (Senior / Advanced) Clinical Study Manager to join our Clinical Affairs team at Brainlab.

In this role, you will independently lead clinical studies and medical device investigations from concept to completion, ensuring high-quality execution, regulatory compliance, and timely delivery of clinical evidence.

You will collaborate closely with Product Management, R&D, Clinical Marketing, and other stakeholders to translate clinical evidence needs and product roadmap priorities into well-designed and successfully executed studies.

Your Responsibilities

Independently plan, initiate, manage, and close clinical studies and medical device investigations, including multicenter and international studies.
Develop and manage study protocols, timelines, budgets, contracts, site selection, investigator relationships, monitoring, data acquisition, data management oversight, and study deliverables.
Ensure compliance with applicable clinical research regulations, ethical standards, and quality requirements.
Maintain accurate, inspection-ready Trial Master Files (TMF/eTMF) and essential study documentation; contribute to the development and improvement of SOPs, work instructions, and clinical research processes.
Collaborate with Product Management, R&D, Clinical Marketing, Regulatory Affairs, and other functions to align clinical evidence generation with product development and business priorities.
Proactively manage study risks, external partners, data quality, and project progress, communicating key milestones and recommendations to stakeholders.

Qualifications

University degree in life sciences, biomedical engineering, medicine, or a related scientific discipline.
5+ years of relevant experience in clinical research, preferably in the medical device industry, with demonstrated independent management of clinical studies or investigations.
Strong working knowledge of EU MDR (2017/745), including Annex XV, ISO 14155, applicable GCP principles, and relevant European and national clinical investigation requirements.
Familiarity with ISO 13485, EU GDPR, relevant MDCG guidance, and clinical research quality management processes.
Hands-on experience with clinical study operations, including TMF/eTMF management, monitoring, clinical data management oversight, site and vendor management, study budgeting, and clinical study agreements.
Experience supporting ethics committee and competent authority submissions and maintaining inspection-ready documentation.
Strong project management, organizational, communication, and stakeholder management skills.
Demonstrated initiative, accountability, and ability to independently manage complex projects with limited supervision.
Fluent in German and English, written and spoken.

Nice to Have

Experience conducting clinical investigations in both Europe and the US, including familiarity with FDA requirements.
Familiarity with clinical evaluation, post-market clinical follow-up (PMCF), and clinical evidence requirements under EU MDR.
Experience in surgical technologies or medical devices related to neurosurgery, spine, orthopedics, ENT, general surgery, or other clinical specialties.
Experience with software as a medical device (SaMD), image-guided surgery, or digital health technologies.
Knowledge of health economics and outcomes research (HEOR), reimbursement pathways, or healthcare coding structures in Europe and/or the US.
Experience supporting scientific publications and dissemination of clinical evidence.
Experience with patient imaging database management.

Benefits