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Senior Data Management Analyst

Employer
Novo Nordisk
Location
Lexington, MA
Start date
Feb 28, 2024

Job Details

About the Department                                                                                                                                             

At Novo Nordisk Research Center Seattle, Inc. (NNRCSI) our scientists apply cutting-edge technologies to early R&D projects with the goal of bringing real change to people with Diabetes and Obesity. Our scientists apply state-of-the-art technologies within the diabetes and obesity areas, with the goal of bringing molecules to market. Your skills, dedication and ambition will help change lives for the better and you will work with extraordinary talent, continuously learn and develop, and drive changes to defeat serious chronic conditions. We recognize the importance of an enjoyable workplace, which stimulates a strong culture of ingenuity and innovation and our support of a healthy work-life balance adds to a best-in-class employee experience. The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop in their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. We are changing lives, are you ready to make a difference?

 

The Position

A clinical trial is driven by a Trial Squad, which has end-to-end accountability for planning, execution and completion. The Senior Data Management Analyst is a standing member of the trial squad alongside the Clinical Project Lead (CPL). (Name of groups and titles of stakeholders may vary for phase I trials and Non-Interventional Studies) The SDMA is accountable for project management and end-to-end trial delivery from data management (DM). Whenever more CTDMs are allocated to a trial, one dedicated Point of Contact (PoC) CTDM will assume the main accountability and other CTDMs will assume a supporting role fulfilling specific job tasks.

 

Relationships

The Senior Data Management Analyst is expected to fulfil a CTDM PoC role for complex trials (incl. new data sources) or across multiple trials. Alternatively, being specialized in a business-critical process or system and capable of applying this expertise across multiple trials. Additionally, mentor more junior colleagues as well as contribute with an innovative mind-set challenging status quo.

 

Essential Functions

  • Participates in the Trial Squad along with the TPM and adjacent functional trial partners providing operational DM input and contribute to trial-related operational decisions
  • Key Area #1
  • End-to-end trial delivery from DM in accordance with project goals, plans and assigned activities
  • DM related project management and oversight of the end-to-end clinical trial (s) on which they have been assigned at any given time
  • DM related project risk identification, issue prevention and resolution, decision facilitation and management reporting
  • Key Area #2
  • Clinical data, which meets applicable regulatory requirements, quality, and data standards, is available in a timely manner
  • There is appropriate involvement of stakeholders as relevant (adjacent DM function)
  • DM related activities follow all existing applicable internal and requirements
  • Team spirit within the team of CTDMs, whenever more CTDMs are allocated to a trial
    • Key Area #3
    • Effective communication and information within the Trial Squad and with key stakeholders
    • DM knowledge to ensure the trial is planned and conducted according to the GD FAST principles, if possible
  • Main job tasks:
  • The Clinical Trial Data Manager (trial related tasks)
  • Participate in and provide inputs to protocol outline and protocol development
  • Define data collection structure and specifications in collaboration with internal and external stakeholders (CRF, external data)
  • Ensure setup of clinical data management systems and interfaces
  • Create, maintain, and execute a Data Management Plan covering all DM activities
  • Ensure creation of a data quality plan on a trial (data checks, blinding ...)
  • Ensure clear and concise communication with operational and functional trial partners (e.g., Data Management Systems and Standards, Biostatistics, Trial Operations, Medical & Science, Clinical Supplies, Global Safety) including timely follow up
  • Use data visualization methods to review / understand data and make operational decisions
  • Perform database lock activities
  • Maintain trial documentation and ensure archival on an ongoing basis
  • Perform post DBL activities to ensure submission ready data
  • Resolves or escalates major issues, supported by PDM and/or Manager of relevant DM unit
  • Prepare for and participate in audits and inspections
    • Other areas of responsibility:
    • Delivering data as a key asset requires demonstration of project- and self-leadership, data literacy as well as excellent communication skills
    • Self-leadership is characterized by a drive for autonomy, ability to make decisions and take responsibility for them, being creative and persistent, even in the face of adversity. The employee is expected to demonstrate self-awareness, self-motivation, and ability to receive and act on feedback
    • Project leadership is characterized by taking ownership and responsibility of trial delivery by driving and motivating teams and peers, planning, executing, and working closely with trial teams to achieve ambitious project deliverables
    • Data literacy is characterized by the ability to read, analyze, and understand data to derive meaningful information from data and take responsibility for relevant actions
    • Excellent communication skills are characterized by an ability to understand complex information in the given context and conveying thoughts and ideas clearly and timely to stakeholders and peers, all in the right context

     

    Physical Requirements

    0-10% overnight travel required. Ability to lift 0-20 lbs.

     

    Qualifications

    • MSc/BSc in Natural/Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications and A degree in computer science or equivalent professional experience
    • 4+ years of relevant experience required
    • Experience of working with clinical systems used in drug development
    • Knowledge of relational database systems
    • Knowledge of clinical development
    • Project management experience and experience
    • Experience in working under quality guidelines and practices (ICH-GCP, ISO)
    • Ability to collaborate / build and maintain solid internal and external networks
    • Personal skills:
    • In-depth knowledge about clinical trial methodology
    • Fluent in written and verbal English
    • Team oriented personality with high degree of flexibility, situational- and cross-cultural awareness
    • Good communication, presentation, negotiation, and influential skills – ability to maneuver in situations of ambiguity
    • Ability and willingness to adjust quickly to new situations in a continuously developing environment
    • Builds strong relationships to and networks with stakeholders and decision makers
    • Act in accordance with the NN Way

     

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk 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.

     

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

     

    If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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