P2617 - Senior Clinical Data Manager

Debiopharm; Lausanne; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Equal-Pay certified

Cross-disciplinary collaboration

Exposure to oncology & anti-infective

Zusammenfassung

Debiopharm in Lausanne, Switzerland, seeks a Senior Clinical Data Manager to lead data management for multiple studies, ensuring high-quality, regulatory-compliant data. You will oversee CRF design, EDC setup, UAT, data review, and database release with close collaboration across a matrix team.

The role requires a strong background in clinical data management, 10+ years of experience, and proficiency with AI-enabled automation.

Qualifikationen

• As strong educational or technical background in sciences or engineering.
• Minimum 10 years of experience in clinical data management in a pharmaceutical environment.
• Experience with Phase 1 to 3 studies; PM experience is a plus.

Aufgaben

• Lead and coordinate CDM activities including CRF design, EDC setup, UAT, and database release.
• Perform data review, query generation, and data coding while ensuring timely data capture.
• Define and manage timelines for multiple studies or development programs.
• Prepare and review Data Management Plans and validation plans in compliance with GCP and SOPs.
• Oversee lock, transfer, and archiving of clinical study databases.
• Act as a key member of the clinical study team with cross-functional collaboration.

Kenntnisse

CDM leadership

EDC systems

AI automation

Data integrity

Planning & scheduling

Communication

Ausbildung

Scientific background

Project Management certification

Tools

EDC platforms

Jobbeschreibung

Together, we innovate, we impact, we grow

AtDebiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company,we'redriven by science, butabove all, bythe people behind every treatment — the patients and their families.

Through our unique "development only" model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.

Are youpassionate about advancing science and improving lives?We are currently looking for adriven,passionateandcollaborativeprofessionalto join ourBiostatistics and Data Management departmentbased at our Headquarters in Lausanne, Switzerland as

Senior Clinical Data Manager

Permanent role | Location: Lausanne, Switzerland

YourMission

As aSenior Clinical Data Manager, you will be accountable for the quality and timelines of data management activities across assigned clinical studies. You will play a pivotal role in ensuring that complete,accurate, and consistent clinical data is available to support our internal decision-making processes.Whether managing internal tasks or overseeing activities outsourced to external providers, you are the guardian of data integrity and quality.

KeyResponsibilities

• StudyLeadership:Lead andcoordinateCDMactivities,includingeCRFdesign, EDC system setup, User AcceptanceTesting(UAT), anddatabaserelease.
• OperationalExcellence:Performdatareview,querygeneration, and datacodingwhileensuringtimelydata capturefrombothinternalandexternalsources.
• StrategicPlanning:Define andmanagetimelines for multiplestudiesordevelopmentprograms.
• Documentation &Compliance:PrepareandreviewData Management Plans (DMP) and validation plans in strict compliancewithGCP, SOPs, andregulatoryguidelines.
• LifecycleManagement:Overseethe lock,transfer, andarchivingofclinicalstudydatabases.
• Collaboration:Actasakeymemberof theclinicalstudyteam,workingcloselywithClinicalTrial Managers andotherstakeholders inamatrixenvironment.

Requirements

Your profile

• Education:Scientific ortechnicalbackground,ideallyat auniversitylevel. In addition, any Project Management certification would be a plus.
• Experience:At least10 years inclinicaldata management,workingin matrixorganizationwith at least onepreviousandsolidexperiencein pharmaceutical industryand supporting Phase1 to3 studies.Project Managementexperience, anasset.
• TechnicalExpertise:StrongexperiencewithvariousEDCsystemsand first experience orproficiencyautomating activities with AI.
• Leadership:Proventrackrecord inleadingdatamanagementstudiesandteamstodeliverhigh-quality,regulatory-compliantdatabases.
• Skills:Excellentorganizational, planning/coordination,proactivityand communicationskills.Techsavvy,especiallywithDigitaltoolsand AI
• Languages:Fluent inEnglish;knowledgeof Frenchisa distinctasset.

Benefits

WhatweOffer:

• Being part of a company where innovation, collaboration, and impactaren'tjust values —they'rehow we work every day
• Partner with teams across disciplines, at the forefront of oncology and anti-infective development
• An inclusive and respectful workplace — proud to be Equal-Pay certified
• Grow in a culture that values people, purpose, and performance
• A chance to grow, share, and shape the future of healthcare