Published date Posted on Indeed on Jun 23, 2022 (11 d ago)
  • Accountable/Responsible to interpret requirements to translate and document them into technical
  • specifications in clinical trials. Provision clinical trial data to business consumers. Facilitate
  • requirements gathering from consumers and develop global solutions to meet immediate and
  • long-term needs of the business. Monitor and maintain ongoing operations of clinical data
  • environments and respond to issues.
  • Leads and oversees all clinical data management tasks performed by an external partner.
  • Oversees CRO capacities/budget for outsourced tasks.
  • Develop/test different ways to constantly improve data reliability, integrity and quality. Ensures
  • real-time inspection readiness of all data collection, data review deliverables for clinical trials and
  • participates in regulatory agency and Client internal audits as necessary.
  • Collaborate with members of the development team at Client on the project goals. Contributes to
  • cross-functional and team-based thinking.
  • Keep abreast of data science and in particular new data collection/curation/standardization/digital
  • tech solutions and innovative processes/tools within and outside Client. Turn derived insights into
  • new clinical data management approaches relevant for clinical development, registration, and
  • marketing of drugs.
  • Conduct and support data collection/curation/standards process and tool trainings for data
  • managers.
  • Participate in or lead cross-functional Client internal process development teams and drive/plan
  • relevant clinical data management (data collection/curation/standardization) aspects.
  • Bachelor's degree from an accredited institution, in Life Sciences, Computer Science,
  • Software/Computer Engineering, or similar preferred, with more than or equal to nine (>/= 9))
  • years of professional experience; Or
  • Master's degree (e.g. MBA, MSc) from an accredited institution, in Life Sciences, Computer
  • Science, Software/Computer Engineering, or similar preferred, with greater than or equal to five
  • (5) years of professional experience.
  • Initial experience within the pharmaceutical industry or CROs.
  • Broad knowledge and advanced experience in understanding of clinical trial development process
  • required.
  • In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data
  • Review Tools, Data Standardization methods and/or basic SAS/SQL programming skill required.
  • Thorough knowledge/experience in design of clinical trials, basic medical terminology and on
  • processing clinical trial information.
  • Demonstrated ability to build/test, curate, oversee and interpret data in complex clinical trials with
  • established experience.
  • Intellectual curiosity to find new and unusual ways solving data collection / curation /
  • standardization / process definition, testing and training issues.
  • Excellent organizational skills, problem solving abilities, negotiation skills and time management
  • skills required.
  • Strong communication skills: Confident and persuasive communicator to ensure that the
  • message is clear and well understood.
  • Ability to work collaboratively on multi-disciplinary project teams and proactively manage
  • relationships with external vendors required.
  • Mindful of local, global, internal and external cultures to ensure that messages are received
  • positively and effectively.
  • Ability to lead and facilitate meetings required.
  • Ability to develop and deliver (technical) training required.
  • Language skills: English: fluent (Read/Write/Speak).

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