Overview
If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us as a Digital Medicine and Translational Imaging Study Manager in Spain, dedicated to a single sponsor.
We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.
You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
The DMTI SM would be critical in ensuring the digital medicine data collected across multiple studies is of the highest quality. To facilitate this will require reviewing and monitoring multiple dashboards to discern if data is being collected as expected, and if there are any necessary actions or issues for follow-up. Examples include confirming whether the participant is in an ‘active wear’ period based on the protocol (ie, when they should be wearing the device), and if so, whether they are wearing it compliantly (based on pre-specified criteria), if data is being transmitted as expected, and if the battery/memory capacity of the device is ok.
Additional Tasks
* Reviews of participant and site guides, attending meetings with vendors and study staff to ensure sites have appropriate materials for start-up and conduct, and to surface or discuss troubleshooting or site-based issues related to the digital medicine portion of the study, and to conduct any pertinent participant follow-ups.
* In operating across multiple DMTI studies, identification of opportunities and trends to enhance standardization and efficiency of operational activities associated with these assessments. Examples include collating lessons learned, FAQs, and study-specific exceptions.
Requirements
* MSc in Statistics, Biostatistics, or a quantitative discipline such as Physics, Applied Mathematics, Bioengineering, or Electrical Engineering, coupled with a high level of statistical expertise. Research experience with mathematical/statistical modeling using complex data and three or more years of industrial or similar experience.
* +5 years experience in the medical device and in the wearable device industry.
* Experience in implementing digital health technologies (DHT).
* Experience with digital health data collected across multiple studies.
* Experience in reviewing and monitoring multiple panels.
* Technical skills: Fluency in R programming.
* Strong background in experimental design and statistical analysis, including inference and probability; competence in contemporary linear and predictive modeling, including longitudinal mixed models, nonlinear regression, and predictive modeling.
* Genuine interest in biology and pharmaceutical development, with the attitude of a self-directed scientist; demonstrated ability to multitask.
* Outstanding communication skills. Ability to explain statistical and modeling concepts to non-experts.
* Demonstrated ability to work effectively as part of a team.
Preferred Qualifications
* PhD in Statistics, Biostatistics, or a quantitative discipline such as Physics, Applied Mathematics, Bioengineering, or Electrical Engineering.
* Research experience with mathematical/statistical modeling using complex data.
* Technical skills: Programming in Python; knowledge of SAS and MATLAB is a plus.
* Pharmaceutical applications desired; early clinical (phase I and phase II) and translational experience is an advantage.
* Knowledge of machine learning algorithms, feature selection, and optimization.
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.
Additional Information
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
For an immediate interview, please contact .
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