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RWE Database Studies Director

United States of America - Remote - Northeast Date posted 11/22/2022 Job ID R0000005034

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

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.

Key Accountabilities:

Accountability Supporting Activities
Project Execution
• 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 :

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

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


#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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