Clinical Development Feasibility Expert FSP

Parexel

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profile Job Location:

Berlin - Germany

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Parexel FSP are currently recruiting for an experienced Clinical Development Feasibility Expert in Germany. This is a 100% remote position and is dedicated to one of our key global sponsors.

In this position you will be an invaluable resource working within the global clinical development and feasibility functions youll support the teams with a quantitative evidence and data driven approach ensuring compelling narratives are developed. You will enhance strategies and execution through descriptive and predictive analytics working with both internal and external data scientists. Youll also support the development and integration of new tools including artificial intelligence and big data to support trial scenario decision making.

Some specifics about this advertised role

100% homebased position

  • Review of Evidence Plans Trial Design Outlines and Clinical Trial Protocols.
  • Review and analysis of information in internal- and external data bases.
  • Presentation of charts and analysis of benchmark data.
  • Establishing Analysis and Consolidation of Metrics and Quality Review regarding Trial- Country- and Site Lists.
  • Running of scenario simulations critical reviews checks and provisions of results in the form of presentations (PPT).
  • Alignment of findings with team members.
  • Establish PPT Presentations Reports and Communication based on templates and examples.
  • Presenting in meetings.
  • Preparation Attention Contribution Minutes Follow-Up in CDPH internal/external meetings.
  • Project Management of upcoming tasks.
  • Proactive communication to CDPH team members trial- and program teams.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas and we have longstanding partnerships with a vast client base.

We supported the trials of most of todays top 50 best-selling drugs but equally we enable more niche drug developments that are critical to the well-being of many patients.

Youll be an influential member of the wider team.

What we are looking for in the this role

For every role we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

  • Prior Experience successful work in a sponsors or CROs strategic feasibility team (planning of programs- and trial scenarios); understanding of country- and site feasibility.
  • Clinical Development Knowledge trial structures and dynamics (Regulatory Timelines Site Initiation Curves Screening Rate and Failure Enrollment Rates and Curves Retention/Drop-Outs) understanding of Clinical Trial Protocols and Trial Designs.
  • Data Analysis & Modeling descriptive (e.g. box-whiskers charts trend analysis percentiles) predictive (Confidence Interval Probability Densities and Curves).
  • Abstract & Mathematical Thinking translation of medical assumptions in quantitative analysis and statistics understanding of limits and opportunities of models and data.
  • Benchmarking & Scenario Planning internal/external comparisons identification of trends descriptive statistics.
  • Quantitative Forecasting country- site- patient-number estimations enrollment rates timelines.
  • Tool proficiency advanced and expert MS Office knowledge Especially Expert Excel knowledge.

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When our values align theres no limit to what we can achieve.At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in...
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About Company

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Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more

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