Real-World Evidence Consultant (Secondary Database Analysis)
Sweden, Remote Job ID R0000028042 Category Regulatory / Consulting Date Posted 10/01/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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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