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Trial Data Manager (eCRF)


Posted on Feb 4, 2021 by Aerotek

Basel, Switzerland
1 Apr 2021
Annual Salary

Dear network,

Our client, a pharmaceutical company, is looking for a Trial Data Manager to join their team and bring his/her experience in managing clinical trials data, ensuring data management activities are up to highest standards and represent the clinical trial team during meetings.

This opportunity offers the possibility to work in a dynamic environment for a company where individual contribution are extremely valuable.

The main tasks and responsibilities are:

  • Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Idorsia Standards, and applicable regulations

  • Meets study timelines in terms of Data Management deliverables

  • Ensures data handling consistency within allocated study(ies)

  • Leads Data Management activities for assigned study

  • Provides Data Management input to the development of the study protocol

  • Coordinates the development of the (e)CRF in line with Idorsia standards

  • Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated study(ies)

  • Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning/review tools, and their implementation in the production environment=

  • Organizes, monitors and tracks data cleaning, data review, query management, and database lock. Makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders

  • Generates study metrics and status reports

  • Represents Data Management at Clinical Trial Team (CTT) meetings

  • Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners' management)

  • Prepares and archives Data Management study documentation

  • Presents study related topics at CTT, Investigators and Monitors meetings

  • Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management

  • Represents Data Management in cross functional working groups related to the system/process

  • Forecasts study team resource requirements

  • Ensures Data Managers assigned to study have required training

  • Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.XML and annotated CRF) are created, validated and provided as per agreed timelines

  • Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handles according to protocol, applicable Quality System (QS) documents and GCP

If you:

  • Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines

  • At least 3 years' experience in Pharmaceutical or Biotech industry within Clinical Research and/or Clinica

  • Data Management with good level of functional expertise in Data Management

  • Good knowledge of international clinical research regulations and requirements (eg, International Conference on Harmonization - Good Clinical Practice (ICH/GCP)

  • Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design

  • Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study

  • Good organizational and presentation skills

  • Fluent in written and spoken English

Then please contact me via email (see below) with your earliest availability for a short chat, where I would be happy to give you all the details.

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to our website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1082083444

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