Clinical Development Feasibility Expert - FSP - Remote

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, you’ll 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. You’ll 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 today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll 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 sponsor’s or CRO’s 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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