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P2518 Senior Clinical Data Manager (Early Phases)
P2518 Senior Clinical Data Manager (Early Phases)Debiopharm • Lausanne, Vaud, Switzerland
P2518 Senior Clinical Data Manager (Early Phases)

P2518 Senior Clinical Data Manager (Early Phases)

Debiopharm • Lausanne, Vaud, Switzerland
Vor 30+ Tagen
Stellenbeschreibung

Description

We are currently looking for a motivated and collaborative professional to join our Data Management and Biostatistical department based at our Headquarters in Lausanne Switzerland as

Senior Clinical Data Manager early phases

As a Senior Clinical Data Manager you wont just manage data; you will be the data strategy leader for assigned clinical studies pioneering innovative approaches to data flow quality and accessibility. You are accountable for ensuring the timely availability of complete accurate and consistent clinical data to support critical and rapid internal decision-making particularly in our early-phase and adaptive trials.

You will act as the key liaison between the technology and clinical functions leveraging your expertise in modern data capture and cleaning tools to support smart efficient clinical development.

Your Mission.

Innovation & Data Strategy :

  • Pioneer Data Integration : Drive the strategy for integrating complex data sources (e.g. ePRO wearables central lab biomarker data) into the Electronic Data Capture (EDC) system and clinical database for unified streamlined analysis
  • Agile Data Management : Define and manage timelines for multiple clinical studies or development programs applying agile data management principles to support the fast-paced adaptive needs of early-phase clinical development
  • Smart Cleaning & Validation : Oversee and / or perform the setup of sophisticated EDC systems and data validation plans implementing risk-based and automated data quality checks to focus manual review efforts on the most critical data points
  • Technology Leadership : Act as a key technical reference for transversal activities coordinating the evaluation and implementation of new data management tools and technologies to enhance efficiency and quality across the department

Oversight Quality & Compliance

  • End-to-End Oversight : Prepare review and ensure execution of comprehensive Oversight Plans and Data Management Plans (DMPs) maintaining accountability for all outsourced and in-house data management activities.
  • EDC & Database Mastery : Lead the full lifecycle of the clinical database including complex Electronic Case Report Form (eCRF) design User Acceptance Testing (UAT) database release and final lock / transfer / archive ensuring the system supports evolving study protocols.
  • Data Integrity Champion : Ensure ongoing and timely data capture cleaning and reconciliation activities. Champion data quality according to industry standards and strict data integrity principles (ALCOA).
  • Ensure that all data management activities are fully compliant with GCP applicable regulatory guidelines and company Procedural Documents.
  • More than a checklist of skills were looking for someone who shares our commitment to science with purpose.

    Requirements

  • Master in Life Sciences or similar education
  • At least 8 years of progressive experience in Clinical Data Management at Sponsor Pharmaceutical & Biotech
  • Proven experience as the lead Data Manager overseeing the end-to-end data management strategy for an entire development programs particularly those supporting complex or adaptive trial designs.
  • Strong hands-on experience utilizing and optimizing several industry-leading EDC systems (e.g. Rave InForm) and related data management and cleaning technologies.
  • Experience managing data for early-phase (Phase I / II) studies is a significant advantage demonstrating an ability to rapidly adjust to protocol changes and expedited timelines.
  • Exceptional planning organizational and communication skills essential for managing multiple parallel study timelines.
  • Ability to effectively work and collaborate as a key member of the clinical study team within a complex matrix organization.
  • Fluent in English; good knowledge of French is an asset
  • Team oriented you look for a collaborative workspace where your can share & learn with and from your colleagues
  • What to Expect in the Recruitment Process :

    If your application is selected youll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by a panel interview and reference checks. Communication is handled via Workablecheck your spam folder for emails from

  • @ .
  • Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.

    Benefits

  • Being part of a company where innovation collaboration and impact arent just values theyre how 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
  • Required Experience :

    Manager

    Key Skills

    SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

    Jobalert für diese Suche erstellen

    Data Manager • Lausanne, Vaud, Switzerland

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