Digital therapeutics (DTx) is one of the fastest growing, most exciting and most innovative areas in medicine right now. Business analysts expect a tenfold growth globally in DTx by 2030. With the passing of the digital health care law (DiGAV) in Germany in 2021, digital therapeutics are guaranteed to continue to grow in importance as it allows patients and their doctors to interact in a remote manner with the goal of providing accessible health care which complements more traditional types of medicine such as pharmaceutical therapies.
Allied Clinical Management and its recruiting division, ACM Recruiting, are collaborating closely with a scientific/academic consulting CRO which advises digital therapeutic companies on creating an effective pipeline for their products. Our client is hiring a Senior Scientific Clinical Research Manager who will play a key role in developing evidence based RCTs to help digital therapeutics companies gain approval for their pipeline in order to create a real world impact for patients.
ACM Recruiting has an exclusive contract to provide our client with a Senior Scientific Clinical Research Manager who is interested in working with innovative digital healthcare companies. This is an ideal time for the right person to make a mark in developing DTx to help people get the treatment they need. The location is in Berlin, one of the most vibrant and exciting cities in Europe!
The Senior Scientific Clinical Research Manager position is a combination of science and clinical research. If you have a PhD in the life sciences and 2-3 years of post-doc research experience with an additional 4-5+ years of industry experience with medical device trials (preferred) or pharmaceutical trials, then you are probably a very good candidate.
From the clinical operations side, the Senior Scientific Clinical Research Manager will be responsible for the planning, organization and execution of clinical studies - mostly medical devices (DTx). You may also be involved in some pharmaceutical trials - but the emphasis will be on digital therapeutics. In this role, you will prepare trial documents such as clinical investigational plans and regulatory documents. If you have not yet managed a medical device trial, you must at least be very familiar with the EU Medizinproduktverordnung (Medical Device Regulation) from 2020 and the Digitale-Gesundheitsanwendung-Verordung (DiGA) as you will be participating in regulatory strategic consulting with DTx sponsors with regard to their clinical development of their products. The rest of the responsibilities should be familiar to you as an experienced Clinical Research Manager (leading a core team, timelines, study set-up, data cleaning, planning statistical analyses etc.) You should be able to work effectively in a cross-functional team using your strong interpersonal skills.
From the scientific angle, the Senior Scientific Clinical Research Manager is someone with an affinity for scientific research who enjoys reviewing and analyzing clinical data to synthesize key messages drawn from this data. You love research and can't wait for the statistical analysis of data to begin! You will write reports and publications and there will be opportunities to present these at scientific fora. You will also conduct some systematic literature searches and evaluations. You will have the opportunity to mentor junior scientists and doctoral students.
Und da die Stelle in Deutschland angesiedelt ist, verfügen Sie natürlich über professionelle oder muttersprachliche Deutschkenntnisse!
If this sounds like you, we would love to receive your CV and any supporting documents!