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Trial Data Manager

FlexsisAllschwil, Basel-Landschaft, Switzerland, Basel-Landschaft

Data Management activities for assigned clinical trials, ensuring high-quality, consistent data delivery in line with internal standards, applicable regulations, and agreed timelines.The role coord... Mehr anzeigen

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bigawin agBasel, Basel City, Switzerland
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Machine Learning Architects Basel (MLAB)Basel, Basel City, Switzerland
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Senior Process Engineer

PM GroupBasel, Basel-Stadt, Switzerland

PM Group is an employee-owned, international project delivery firm with a team of over 3,800 people.We are world leaders in the pharmaceutical, food, medtech, and mission-critical sectors.From our ... Mehr anzeigen

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HuntsmanSwitzerland, Basel
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To support our Technology Department in the Advanced Materials division, we are looking for an.The position is a 6-month internship based at our Advanced Materials Innovation Center in Basel, Switz... Mehr anzeigen

Data as a Product Lead

LonzaSwitzerland, Basel

Today, Lonza is a global leader in life sciences operating across five continents.While we work in science, there’s no magic formula to how we do it.Our greatest scientific solution is talented peo... Mehr anzeigen

Junior SAP System Engineer

CoopAllschwil, ch
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Die Coop Pronto AG ist ein Unternehmen der Coop Gruppe.Als führendes Schweizer Unternehmen im Convenience-, Tankstellen- und Energie-Bereich betreiben wir ein Netz von über 320 Coop Pronto Shop mit... Mehr anzeigen

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The Data Centre Engineer designs, implements and maintains enterprise compute, storage and virtualisation platforms, ensuring that core Data Centre services are secure, resilient, scalable and capa... Mehr anzeigen

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Bank CIC (Schweiz) AGBasel

Teil der CIC (Schweiz) zu werden, bedeutet, in einem flexiblen und dynamischen Umfeld tätig zu werden, in dem unternehmerisches Denken und Kompetenzentwicklung im Mittelpunkt stehen.Mit unserer übe... Mehr anzeigen

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IWB Hauptsitz4002, Region Basel, Schweiz

IWB versorgt Menschen und Unternehmen in der Region Basel mit Strom, Wärme, Trinkwasser, Telekom- und Mobilitätslösungen.Zudem gestaltet IWB die klimafreundliche Energiewelt von morgen.Freue dich a... Mehr anzeigen

Data Scientist / Engineer - DNA-Encoded Library Technology (DELT)

1201 F. Hoffmann-La Roche AGBasel, CH
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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... Mehr anzeigen

Data Scientist (w/m/d)

Pax, Schweizerische Lebensversicherungs-Gesellschaft AGBasel, BS, Switzerland
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Du gestaltest die Transformation zu einem nachhaltig datengetriebenen Unternehmen aktiv mit.Du übernimmst Verantwortung für die Konzeption und Umsetzung datenbasierter Lösungen gemeinsam mit einem ... Mehr anzeigen

Senior Engineer Gebäudeautomation

addexpert GmbHBasel, Switzerland

Technik, die Verantwortung übernimmt.Unser Kunde ist ein international tätiges Ingenieur‑ und Designunternehmen, das seit Jahrzehnten komplexe Projekte in den Bereichen Gebäudetechnik, Life Science... Mehr anzeigen

Project Engineer (Life Sciences)

agap2 - HIQ ConsultingBasel, Basel City, Switzerland
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Senior Scientific Data Engineer

TetraScienceBasel, BS, CH
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TetraScience is the Scientific Data and AI Company building Tetra OS, the operating system for scientific intelligence.We help the world’s leading life sciences firms turn fragmented scientific dat... Mehr anzeigen

Software Test Engineer

SwissPeak Partners GmbHBasel, BS, CH
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Trial Data Manager

Trial Data Manager

FlexsisAllschwil, Basel-Landschaft, Switzerland, Basel-Landschaft
Vor 30+ Tagen
Stellenbeschreibung

Functieomschrijving

Description of the company

The Trial Data Manager leads end-to-end Data Management activities for assigned clinical trials, ensuring high-quality, consistent data delivery in line with internal standards, applicable regulations, and agreed timelines. The role coordinates eCRF development, data review and query management, database lock, and SDTM-related deliverables while partnering closely with Clinical Development and other cross-functional stakeholders.

Role & Responsibilities

  • Lead Data Management activities for assigned clinical trials and ensure adherence to clients standards, applicable regulations, and study timelines.
  • Provide Data Management input into clinical trial protocols and coordinate the development of electronic Case Report Forms (eCRFs).
  • Author trial-specific Data Management documentation, including specifications for external data transfers, data cleaning, and review tools.
  • Coordinate and track testing of eCRF screens, data-cleaning tools, and review tools through implementation in the production environment.
  • Plan, monitor, and drive data cleaning, data review, query management, and database lock in collaboration with key Clinical Development stakeholders.
  • Generate trial metrics and status reports, represent Data Management in Clinical Trial Team meetings, and present relevant topics at investigator and monitor meetings.
  • Manage Data Management activities delivered by outsourced or insourced partners and remain accountable for quality, timelines, and deliverables.
  • Ensure annotated CRFs are created, validated, and delivered according to agreed timelines, and coordinate periodic quality-control checks.
  • Forecast trial-team resource requirements, ensure assigned Data Managers have the required training, and provide functional direction to colleagues supporting the same trial.
  • Contribute to Data Management policies, SOPs, associated documentation, and cross-functional system or process improvement initiatives.
  • Act as the Data Manager for studies where no dedicated Data Manager is assigned.

Candidate Profile

  • Master's degree in life sciences, mathematics, statistics, informatics, or a related discipline.
  • At least 3 years of experience in the pharmaceutical or biotechnology industry within Clinical Research and/or Clinical Data Management.
  • Strong functional expertise in clinical data management, including clinical trial databases and applications, clinical data flow, data review, and eCRF design.
  • Experience coordinating or leading Data Managers and other contributors working on the same clinical trial.
  • Experience managing outsourced Data Management activities or external service partners is highly relevant.
  • Good knowledge of international clinical research regulations and requirements, including ICH Good Clinical Practice (ICH/GCP).
  • Ability to organize multiple deliverables, maintain oversight of timelines and quality, and communicate clear priorities.
  • Confident collaboration across Clinical Development and other cross-functional stakeholder groups.
  • Strong presentation and stakeholder-management skills.
  • Advanced written and spoken English.