Data Management Oversight Specialist

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Søborg

Do you want to play a critical role in coordinating our oversight efforts in ensuring the quality, accuracy, and integrity of [xxxxx] outsourced clinical trial data? Do you have experience in working in clinical data management and a firm knowledge of clinical drug development? Are you looking to leverage your domain knowledge, technical acumen and strong communication skills while enabling Data Management oversight capability at [xxxxx]? Then you could be the one driving the oversight of Data Management deliverables in outsourced clinical studies. Join our Data Management oversight team as a Data Management Oversight Specialist. Apply today and join us for a life-changing career. The Position
In this role, you will be responsible for consolidating and optimizing how oversight of Data Management deliverables from our partner vendors will be performed. This includes enhancing guidance and procedures, developing innovative oversight approaches, developing tools and defining data-driven approaches to oversight of Data Management deliverables. This role will also develop training and take responsibility for enhancing oversight skills across the Clinical Data Operations & Insights organization. You will collaborate closely with our data science outsourcing team and other stakeholders supporting that all partner vendor data deliverables meet Novo standards and are conducted in an efficient, effective, and ethical manner. Your responsibility will also be to:
  • Collaborate closely with internal stakeholders to define requirements, timelines, and deliverables.
  • Together with the Data Management Outsourcing team and Biostatistics oversight team, ensure compliance with regulatory requirements, internal quality processes, and industry standards.
  • Identify and mitigate risks associated with Data Management oversight and develop best in class oversight methodologies and tools
  • Qualifications
    We realise that few people are experts at everything, but if you have the majority of the following attributes then you could be the person, we are looking for:
  • MSc, PhD degree in Natural or Technical Sciences (or equivalent theoretical background – please qualify in application)
  • 7 years of experience within clinical development in Data Management, ideally with a focus on oversight of outsourced clinical trials
  • Expert in Data Management systems and processes
  • Strong knowledge of regulatory requirements related to the conduct of clinical trials and data deliverables.
  • Excellent communication and collaboration skills, with the ability to work closely with vendors, data science team members, and other stakeholders
  • Strong problem-solving and critical thinking skills, with the ability to drive decision making and identify areas for improvement
  • Strong competencies in creation of reports, dashboards, automated status reporting and/or reporting tool skills such as Power BI, Spotfire etc.
  • About the department
    In the [xxxxx] Development function, we are responsible for managing clinical drug development worldwide, ensuring that our processes follow global standards, regulations and business ethics while still delivering viable and innovative medicine. We are a strategic function to the Data Science organisation. We provide strategic support and part of driving cross functional strategic initiatives. The team consist of engaged self-driven experts with a diversity of scientific backgrounds, such as data science and statistics, programming and in-depth knowledge across Biostatistics and Data Management processes, innovation, automation, digitalization tools and strategy development. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
    For more information, please reach out to reach out to VP Data Management Systems and Standards, Rhona O Donnell at [xxxxx] . Deadline
    April 12th, 2024 Please notice that applications will be processed as they are received. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 21.3.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Softwareudvikler
    • Søborg

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