Trial Data Manager

Employer
CTC Resourcing Solutions
Location
Basel, Canton of Basel-Stadt (CH)
Salary
Negotiable
Closing date
2 Oct 2020

View more

Discipline
Data Management / Statistics, Clinical Data Management
Hours
Full Time
Contract Type
Contract
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Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Trial Data Manager for a 12 months contract based in Basel area.

The ideal candidate should have 3 years of previous experience in Pharmaceutical or Biotech industry within Clinical Research or clinical trials.

Main Responsibilities:

  • Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Company 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 Company 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.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required;
  • 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 (e.g., 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.

Due to our reputation for excellence and our proactive approach to networking and promoting CTC, we are able to engage the very best talent, and consequently work with the very best employers in the market who are serious about bringing talent to their organisation. If you are looking for a reliable partner with:

  • Established client and candidate network
  • Excellent and detailed knowledge of local requirements
  • Solid reputation
  • Quick and flexible approach to recruitment
  • High quality of service
  • People focused

Depending on your needs and situation, we offer business partnerships with flexible solutions that can be tailored to your specific resourcing needs - all with a collaborative, open, and friendly approach.

We recruit in the following areas:

  • Pharma/Biotech:
    • Clinical Development
    • Pre-Clinical Development
    • Regulatory affairs
    • Pharmacovigilance
    • Sales & Marketing
    • Supply Chain
    • Communications
    • Medical Affairs
    • General Management
  • Medical Devices / MedTech:
    • Engineering & Product Development
    • Quality & Manufacturing
    • Technical Writing
    • Regulatory Affairs
    • Sales & Marketing
Contact Us
  • Münchensteinerstrasse 41
  • Münchensteinerstrasse 41
  • Basel
  • CH
  • +41 61 695 88 66
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