Signant Health

  • Senior Clinical Scientist

    Job Locations CZ-Prague
    Job ID
    2019-4170
    Category
    Hidden (50021)
    Position Type
    Permanent Employee - Full-Time
  • Role Overview

    The Senior Clinical Scientist is responsible for a portfolio of complex projects and for each project provides development and delivery of clinical products/services including training, endpoint reliability, and data analytics. The Senior Clinical Scientist works collaboratively with internal teams and sponsor teams to define and build the training and endpoint methodologies and materials, and will directly participate in their execution through attendance at face-to-face and virtual training events. The Senior Clinical Scientist is responsible for evaluating data according to approved methodologies and presenting data reports to the sponsor, and will participate in business development activities including scoping opportunities and participating in capability and bid defenses. The Senior Clinical Scientist will work with development teams to design, build and test eCOA needs for their projects and for potential opportunities.

    Key Accountabilities/Decision Making & Influence

    • Conducts all activities in full accordance to Good Clinical Practice guidelines.
    • Assumes responsibility for a portfolio of projects, and for each project provides comprehensive, scientifically sound clinical services which may include protocol and scale review/feedback, development of site rater and central rater/reviewer training and endpoint reliability methodologies, creation of case studies and quiz questions, and audio/video scripts and recordings, all in accordance with study specific sponsor requirements and best practice
    • Presents trainings live or via webex to site raters, central raters/reviewers and study staff; presents endpoint and data analytic results to clients.
    • Evaluates site rater and central rater/reviewer submitted data in accordance with endpoint reliability and data analytic programs; contacts site rater and central rater/reviewer to gather additional information and provide feedback and retraining as needed.
    • Proactively evaluates opportunities and leads efforts to develop durable licensed scale and topic training materials.
    • Identifies and provides approval for scale version to be used in project; communicates with scale author and sponsor as needed.
    • Works with development team to build and test eCOA instruments. Writes eCOA Clinical Verfication Testing clinical scenarios and scripts.
    • Develops scale specific eCOA data edits, flags and indicators for data quality assurance.
    • Defines and designs project specific endpoint reliability services which may include central review of flags and review of audio/video recordings of scales and exams administered and scored by site or central raters; develops and maintains central rater/reviewer QC program, collects calibration and QC data and works with team to evaluate clinical significance and develop actions as needed. Writes and updates endpoint methodologies and central review QC programming.
    • Ensures compliance with quality assurance as outlined in WIs/SOPs/Clinical Operations Guidelines.
    • Participates in business development opportunities as assigned (e.g., scopings, client meetings, bid-defenses, preparation of materials).
    • Attends conferences and scientific meetings as appropriate.

    Decision Making & Influence

    • Facilitates and maintains team and CoE culture of collegiality, respect, and professional support.
    • Considers all products and services in the context of providing the clinical trial study subject with an optimal clinical trial participation experience; identifies areas for product and service improvement; provides feedback based on practice for areas of potential research; participates in patient centric research efforts.
    • Enhances the Signant Health business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently.
    • Ensures consistency of product with actual project scope and makes decisions to resolve ambiguities in collaboration with both internal and external project teams.
    • Correctly identifies and escalates potential project risks and issues to project team, sponsor and/or manager.
    • Participates in the generation and development of abstracts and posters.
    • Enhances the Signant Health client service business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently.
    • Participates on committees as assigned, serves as clinical stakeholder for product teams as needed.

    Knowledge, Skills & Attributes

    • Advanced science degree plus clinical experience plus research experience or at least 2 years in the Clinical Scientist role.
    • Excellent scientific writing and oral communication skills.
    • Confident presenter.
    • Knowledge of statistics and competency working with data and numbers.
    • Excellent computer skills including Word, Excel and PowerPoint.
    • Ability to learn and adapt to new platforms.
    • Ability to work successfully in a team culture with staff at all levels and across various disciplines; ability to diplomatically resolve conflicts and differences while maintaining positive professional relationships
    • Demonstrated strong analytical, organizational, creative problem solving.
    • Ability to succeed in a fast-paced, entrepreneurial environment.
      Willingness to maintain a flexible schedule; successfully manages own time, proactively identifies and prioritizes multiple tasks.
    • Fluency in English (will be required to write, speak and understand English to conduct day-to-day business).

    Desirable

    • Experience in data analytics.
    • Poster or journal article publication experience.
    • Experience in people management and leading teams.

    IND1

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