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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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Lead Scientist, Visual Inspection Reference Standard Manufacturing

Clear Solutions LaboratoriesBasel, Basel City, Switzerland
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About Clear Solutions Laboratories.Clear Solutions Laboratories is a rapidly growing analytical service provider supporting pharmaceutical and biotech companies in ensuring product quality and comp... Mehr anzeigen

Innovation Scientist – Solid-State Development 100%

Corden Pharma International Switzerland GmbHLiestal

Innovation Scientist (Postdoc, Chemist) – Solid-State Development 100% (m/w/d).Innovation Scientist (Postdoc, Chemist) – Solid-State Development 100% (m/w/d).CordenPharma is one of the leading Cont... Mehr anzeigen

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Clinical Data Manager 50%

HEMEX AGLiestal, Basel-Landschaft, Switzerland
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Join HEMEX, A European Contract Research Organization based in Liestal, Switzerland, dedicated to advancing global healthcare through innovative biotechnology research.As a Medical Monitor speciali... Mehr anzeigen

Scientist

ProclinicalBasel, Schweiz

Ready to lead science projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!.Proclinical is seeking a Scient... Mehr anzeigen

Associate Principal Scientist / Bioanalytical Expert 80-100% (f/m/d)

LonzaSwitzerland, Basel

The actual location of this job is in Basel Stücki, Switzerland.For our successful Drug Product (DP) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities.Become pa... Mehr anzeigen

Senior Data Engineering Consultant (German-speaking)

Machine Learning Architects Basel (MLAB)Basel, Basel City, Switzerland
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At Machine Learning Architects Basel (MLAB), we assist and empower people and organizations in designing, building, and operating reliable data and machine learning solutions.In doing so, our data ... Mehr anzeigen

Lead Chemical Process R&D Scientist

ITech Consult AGBasel

Lead Chemical Process R&D Scientist:.Pharmaceutical Chemical Process/ chemical drawing tools / R&D / CDMO / Design of Experiments / Synthetic Organic Chemistry / Leadership & Project Management / M... Mehr anzeigen

Global Product Safety Science Lead

SobiBasel, Basel-Stadt, Switzerland
HomeofficeHomeoffice

Product-level safety ownership.Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).Set the strategy for safety signal detection methodology, ... Mehr anzeigen

Data Engineer – Python / Airflow / Azure Databricks (m/w/d)

PROSTAFFBasel

Für ein anspruchsvolles Data-Engineering-Projekt bei einem etablierten Unternehmen in der Schweiz suchen wir einen erfahrenen Data Engineer.Im Fokus stehen die Weiterentwicklung einer bestehenden O... Mehr anzeigen

Data Administrator Lead

solviasKaiseraugst, AG, 4303, CH

The Data Administrator Lead is responsible for building and operating a trusted, scalable, and governed data foundation across Solvias.This is the first hire in the Data & AI Office, combining hand... Mehr anzeigen

Senior/Principal Scientist, Medicinal Chemistry

Ridgeline DiscoveryBasel, Basel-Stadt, CH

Versant Ventures Discovery Engine, creates and operates Versant-financed innovative biotech companies in partnership with entrepreneurs, industry, and leading academics across Europe.In recent year... Mehr anzeigen

CSV Lead

Lonza Group AGBasel

Join our Global Engineering team in Basel on a 12-month contract to define, coordinate, and deliver the integrated commissioning, qualification, and computer systems validation (CSV/C&Q) framework ... Mehr anzeigen

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Data Centre Engineer - Storage, Compute and Virtualisation

AvaconeBasel, BS, CH
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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

Manager - Artificial Intelligence & Data - (Data Management & Data Platforms focus)

DeloitteBasel

Help our clients navigate the future with confidence and embrace decision making with clear data-driven choices.Deloitte AI & Data helps clients unlock the power of AI and data to deliver better hu... Mehr anzeigen

In Vitro ADME Scientist

RM IT Professional Resources AGBasel, Switzerland

Basel based client in the Pharma sector.Perform cellular-based in vitro ADME assays, including routine cell culture techniques such as cell seeding and maintaining cell lines.Support drug discovery... Mehr anzeigen

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Senior Clinical Trial Scientist

CTCBasel and NW Switzerland, CH

Develop a sound understanding of the science and medicine related to an indication and trial.Main deliverables include the clinical trial protocol and related documents.Provide input into and revie... Mehr anzeigen

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

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IIoT & Digital Solutions Team Lead

TalentCloud Group RecruitmentBasel, Switzerland
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IIoT & Digital Solutions Team Lead.Industrial IoT, industrial digitalisation or automation.We are supporting an established international technology organisation in the appointment of a an.IIoT... Mehr anzeigen

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Trial Data Manager

Trial Data Manager

FlexsisAllschwil, Basel-Landschaft, Switzerland, Basel-Landschaft
Vor 20 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.