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Real-World Evidence Consultant (Secondary Database Analysis)

Sweden, Remote ID de la oferta R0000028042 Categoría Regulatory / Consulting Fecha de publicación 10/01/2024
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Overview

Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.

Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.

Perfil del éxito

¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?

  • Comunicador
  • Estratégico
  • Constructor de relaciones
  • Solucionador de problemas
  • Orientado al detalle
  • Impulsado por los resultados

Acerca de este rol

Consultant Real-World Evidence (Secondary Database Analysis)

Job Purpose:

A Consultant;

* provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives.

* serves either as an individual contributor, a workstream lead or provides overall project leadership.

* provides guidance to project team members on technical/process issues.

Essential Knowledge and Experience Required:

  • A minimum of 5 years’ experience working with in real-world evidence, with particular emphasis on large relational databases, processing large administrative healthcare datasets (medical and pharmacy claims), and or clinical databases (Electronic Health Records), creating final analytical  
    databases, conducting secondary data analyses, and developing research study designs. 
  • Recent Pharmaceutical/CRO experience preferred. 
  • Experience in Real World Evidence, epidemiology, or register studies. 
  • Past experience in the development of real world evidence proposals is an advantage. 
  • Demonstrated evidence of publications will be viewed favorably. 

Education:

  • Minimum Master’s degree (PhD preferred) in the area of outcomes research, epidemiology, biostatistics, statistics, health services research, or a related field. 

Skills:

  • Strong project management skills. 
  • Good presentation skills. 
  • Process knowledge on primary data collection from sites. 
  • A high degree of written accuracy and attention to detail. 
  • Strong communication skills, especially in the relaying of technical information and project concepts. 
  • Fluent English, another European language will be a strong asset (preferably a Scandinavian language). 

Key Accountabilities of this Role:

Supporting Activities

Project Execution

  • Coordinate a project team of analysts to ensure timely delivery of projects to a high standard, managing client communications, and ensuring projects are delivered on budget. Including project planning and execution. 
  • Coordinate real-world data collection processes from  sites and data register. 
  •  Lead client engagements activities. 
  • Provide technical leadership and training to more junior staff within the team, and ensure own skills are up to date; contribute to thought leadership initiatives. 
  • Apply data analytics to support research projects and collaborations within the team. This will include supervising the conduct of statistical analyses, analytic datasets creation, and performing quality control. 
  • Leading development study protocols, statistical analysis plans and coaching the team through the analytical work process, specifically determining data structures and statistical coding algorithms. 
  • Follow comprehensive quality checking and validationprocesses.
  • Develop study protocols and define analytical variablescollaboratively with external researchscientists andbiostatisticians.

Business Development

  • Continuously develop existing processes to make more efficient and higher quality.
  • Lead development of data acquisition processes.
  • Control project out-of-scope activities with clients andmanage contracting of change-in-scope.

Parexel related responsibilities

•    Adhere to Parexel wide and Regulatory & Access processes at all times. 


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