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Trial Data Manager


Posted on Jul 20, 2021 by Aerotek

Basel, Switzerland
Health Care
Immediate Start
Annual Salary

Our client, a top Pharma company based in Basel is looking for a Trial Data Manager.


Ensures that Data Management (Biometry) activities (related to assigned study) adhere to the client's 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 client's 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

Work is expected to be performed on the premises

Acts as DATA MANAGER for studies where no DM is assigned

Candidate's Experience

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 Clinical

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

Job Title: Trial Data Manager

Location: Basel, Switzerland

Rate/Salary: 0.00 - 1.00 CHF Hourly

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, 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 available on the website.

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 the 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: 1260248191

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