The growing opportunity of clinical data management in Ukraine

Many specialized positions, even entry-level, in the pharmaceutical industry require training above and beyond standard University degree programs. A shortage of specialized clinical data managers in Ukraine means private sector companies are developing internal resource training programs to deepen their pool of available candidates. Given the strong medical education system and established IT outsourcing industry, we believed developing a pool of talented clinical data managers within Ukraine was a feasible goal.The IT outsourcing industry is the second largest export service industry in Ukraine, and one of the main sectors in the economy. More than 50% of Ukraine's IT services revenue came from the United States, the rest mostly from the EU.[1] Ukraine has built a workforce adapted to IT outsourcing, but the lack of local professionals in the fields of clinical data management and clinical data science hinders similar growth in the clinical research sector. Ukraine has a well-established medical education system that trains its healthcare professionals in accordance with EU regulations. Hospitals are predominantly state-owned; the private medical sector is almost nonexistent. The academic and non-profit clinical research sectors are small in comparison to Western European countries, and opportunities for careers within them limited. This leads to a 'brain drain' of medical professionals from Ukraine to other countries in search of higher wages and professional advancement. With its strong education system and highly educated medical workforce, Ukraine is an attractive but under-utilised location for clinical studies. [2] There are approximately 30 clinical research sites in Ukraine handling preclinical through Phase IV studies. In December 2020 on clinicaltrials.gov there were 557 active or recruiting clinical trials listed taking place in Ukraine. Regulatory hurdles and approval timelines have greatly improved in recent years.Currently, when CROs wish to hire data managers to assist with local clinical trials in Ukraine, they have to hire non-specialists who must teach themselves on the job. At present there are no university courses or formal training programs within the country for clinical data managers.Following the success of the Clinical Statistical Programming training program developed by our team and offered since 2013 in partnership V. N. Karazin Kharkiv National University,[3] we recently launched an in-house clinical data management training program in partnership between leading Biometrics CROs Cytel and Intego Group. Upon program completion, students have the opportunity to transition into full-time employment. Ours is the first centralized training program for clinical data managers in the country. We already started a conversation with some of the country's leading universities to help them develop a formal educational program in clinical data management. Our internal training program will serve as a pilot and a proof of concept. We expect that many elements, such as curriculum, admission requirements, quality control, internships, etc., will successfully scale up in an academic environment. Our paper will discuss opportunities for the clinical data management sector in Ukraine, the challenges of recruiting data managers from the existing healthcare workforce, the region’s unique strengths, laws and regulations. We also discuss specifics of the internal training program, development of a course syllabus, and transitioning students from coursework into hands-on data management training.Article length: 8 pages. Article reference count: 9 references.---------------[1] AVentures. Software Development in Ukraine, Poland, Belarus and Romania in 2019.[2] Sinichkina L,  Smolina A,  Svintsitskyi V. Positive Changes for Clinical Trials in Ukraine. Applied Clinical Trials. December 2017.[3] Pirbhai E, Glushakov S. Development of a Clinical SAS University Training Program in Eastern Europe. PharmaSUG. 2015.