RWE Database Studies Director
Parexel International Corporation
United States of America - Remote - Northeas
A Director provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. A Director serves either as an individual contributor, a workstream lead or provides overall project leadership. A Director provides guidance to project team members on technical/process issues.
Accountability Supporting Activities
• Provide accountability of project and oversees the project team to ensure timely delivery of projects to a high standard, manage client communications, and ensure projects are delivered on budget. Including project planning and execution. Provide strategic and technical leadership to the project team.
• 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.
• Support development of study protocols, statistical analysis plans and coaching the team through the analytical work
• Follow comprehensive quality checking and validation processes.
• Develop study protocols and define analytical variables collaboratively with external research scientists and biostatisticians.
Business Development • Generate new business through active client engagement, relationship management and through writing and presenting proposals to clients. Drive client meetings along with business development team to present the skills and experience of the RWE team.
• 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 and manage contracting of change-in-scope.
Parexel related responsibilities • Adhere to Parexel wide and Regulatory & Access processes at all times.
Job Qualifications :
• 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
Knowledge and Experience:
• 8+ years’ experience working in real-world evidence, with particular emphasis on large relational databases, processing large administrative healthcare datasets (medical and pharmacy claims), and or clinical databases (eg 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.
• Minimum Master’s degree (PhD preferred) in the area of outcomes research, epidemiology, biostatistics, statistics, health services research, or a related field.
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