Roche
StudyStartUpLead(SSUL)(m/w/d)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Study Start Up Lead (SSUL) (m/w/d) at Roche. Skills: clinical study start-up, regulatory compliance, cross-functional collaboration, stakeholder management, process improvement. ensuring a smooth and highly efficient study start-up. supporting the delivery of clinical studies for patients”
What You'll Achieve.
ensuring a smooth and highly efficient study start-up; supporting the delivery of clinical studies for patients; ensuring timely activation of study centers; ensuring regulatory compliance; ensuring financial and legal compliance; ensuring precise planning; ensuring timelines are met
What They're Looking For.
Must Have
successful completion of a study (MD, PhD, Master or Bachelor) in Life Sciences or a comparable qualification, sound experience in the start-up of clinical studies, regulatory submission processes, cross-functional collaboration, profound understanding of ICH-GCP guidelines, EU-CTR, local regulatory frameworks, experience in managing service providers and CROs, proficiency in clinical systems (e.g. Veeva Vault, CTIS, RIM), strong organizational skills, analytical skills, problem-solving skills, collaborative and adaptive mindset, ability to maintain an overview in complex, matrix-organized and global teams, convincing through attention to detail, fluent in spoken and written English, fluent in spoken and written German
Nice to Have
further postgraduate/master's degree
What You'll Do.
ensuring a smooth and highly efficient study start-up
supporting the delivery of clinical studies for patients
innovatively initiating clinical studies
identifying specific needs in the start-up phase across various therapeutic areas
ensuring a smooth process for patients and study centers
networking intensively with local and global teams as well as CRO partners
efficient and compliant initiation of Roche-sponsored clinical studies
developing effective start-up strategies
managing operational processes
driving process improvements at country and site level
ensuring compliance with all regulatory requirements
leading teams in strategic planning of operational study start-up execution
responsibility for risk management
responsibility for regulatory compliance
responsibility for collaborative work with external stakeholders
managing start-up activities
ensuring timely activation of study centers
ensuring regulatory compliance
managing and controlling the entire budget and contract process
system data maintenance
ensuring financial and legal compliance
ensuring precise planning
collaborating with the global study team
ensuring timelines are met
managing amendments throughout the entire study cycle
identifying opportunities for process optimization and automation
working with regional and global partners to harmonize systems and optimize timelines
communicating with authorities and institutions (e.g. Ethics Committees and Health Authorities)
aligning guidelines and practices for clinical studies
How You'll Work.
Team & Collaboration
networking intensively with local and global teams as well as CRO partners; working with the global study team; working with regional and global partners; communicating with authorities and institutions (e.g. Ethics Committees and Health Authorities)
Communication Scope
fluent in spoken and written English; fluent in spoken and written German; open dialogue
Process & Methodology
strategic planning of operational study start-up execution, managing start-up activities, ensuring timely activation of study centers, managing and controlling the entire budget and contract process, managing amendments throughout the entire study cycle
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position ## ****Dein neues Team**** Als Mitglied des **PDG Country Study Start-Up Teams** liegt dein Hauptaugenmerk darauf, einen reibungslosen und hocheffizienten Studienstart sicherzustellen, um so die Bereitstellung klinischer Studien für Patient:innen zu unterstützen. Du bringst klinische Studien innovativ auf den Weg: Du deckst den spezifischen Bedarf in der Start-up-Phase über verschiedene Therapiegebiete hinweg und garantierst einen reibungslosen Ablauf für Patient:innen und Prüfzentren. In dieser Schlüsselrolle vernetzt du dich intensiv mit lokalen und globalen Teams sowie unseren CRO Partnern (Auftragsforschungsinstituten). ## ****Verantwortlichkeiten | Das erwartet Dich**** In dieser Rolle konzentrierst du dich auf die effiziente und rechtskonforme Initiierung von Roche-gesponserten klinischen Studien. Du entwickelst effektive Start-up-Strategien, steuerst die operativen Abläufe und treibst Prozessverbesserungen auf Länder- und Zentren-Ebene voran – immer unter Einhaltung aller regulatorischen Vorgaben.Deine Hauptaufgaben umfassen: * Strategische Leitung: Du leitest Teams bei der strategischen Planung der operativen Durchführung des Studienstarts, wobei Du die Verantwortung für Risikomanagement, regulatorische Compliance sowie die partnerschaftliche Zusammenarbeit mit externen Stakeholdern trägst. * Operative Exzellenz: Du managst die Start-up-Aktivitäten und stellst eine termingerechte Aktivierung der Prüfzentren sowie die regulatorische Compliance sicher. Du verantwortest und steuerst den g
Applying for this Study Start Up Lead (SSUL) (m/w/d) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Roche?
Real rants from real employees. Read before you apply.