Experience level:
More than 5 years
Education level:
PhD
Languages:
Russian: Native
English: C1
Serbian: A1
Over the past 4 years, I have successfully worked as a Clinical Trial Manager (CTM) in a global CRO, managing international multicenter studies in internal medicine and oncology. Within the past year, I was fully involved in an international oncology study, where I was directly responsible for the India region and also supervised the APAC region, collaborating with sub-CROs in Taiwan and Japan.
Throughout my work, I consistently and effectively communicated with the internal project team in India, the EU, and the USA, as well as with vendors and the Sponsor. I also presented weekly reports detailing regional metrics and achievements. Additionally, I established strong working relationships with the study team, including CRAs, clinical sites, and the internal PM team.
Among my notable achievements are the timely execution of site opening plans, intermediate and final closures of study databases, successful patient recruitment to the study, and effective management of CRAs during study closures. I have also received several letters of appreciation from both the Sponsor and the PM team, recognizing my contributions and dedication.
I have over 16 years of experience in clinical trials. My career began as a primary CRA in an international oncology trial at CRO. Over time, I successfully advanced through various CRA roles and achieved the position of Senior CRA. In this capacity, I worked directly with sites and vendors, internal project team, conducting all types of visits (pre-study visits, site initiation, interm MV, site closure). I primarily focused on large oncology trials, which required meticulous attention to detail, adherence to metrics, and full engagement. Additionally, I gained experience collaborating with regulatory specialists, preparing ICF and other patient materials, reviewing amendments to clinical trial protocols, and handling safety reporting to competent authorities and ethical committees worldwide. My experience spans extensive involvement in Phase 2-3 trials, with less exposure to Phase 1, Phase 4, and post-marketing trials.
I have experience as a Project Manager in a local pharmaceutical company and CRO. My responsibilities included developing draft study budgets, managing personnel, assigning tasks, conducting and monitoring training sessions, writing study management plans and current study documentation, as well as preparing and conducting kick-off meetings.
✅ Experienced Clinical Trial Manager with 15+ years of expertise in global clinical trials, regulatory
compliance, and stakeholder coordination. ✅ Skilled in risk assessment & mitigation, ensuring
efficient trial execution and high-quality results. ✅ Proven ability to lead multidisciplinary teams,
ensuring studies meet GCP, FDA, EMA, and local regulatory standards. ✅ Extensive experience in
managing EDC systems (Medidata Rave, InForm, eTMF Veeva Vault) and optimizing workflow
processes. ✅ Adept at liaising with regulatory agencies, successfully leading submissions and
compliance strategies. ✅ Strong background in budget management, contract negotiations, and
vendor oversight within clinical research.
Multitasking & Proactiveness – Ability to manage multiple priorities with efficiency and precision.
✅ Flexibility & Adaptability – Quickly adjust to dynamic PVG and trial environments. ✅ Analytical &
Problem-Solving Skills – Strong ability to assess challenges and implement effective solutions. ✅
Communication & Presentation – Excellent ability to convey complex PVG and trial data to
stakeholders. ✅ Detail-Oriented & Client-Focused – Ensuring accuracy in documentation and
compliance with industry standards. ✅ Solution-Oriented Mindset – Independent thinker with a
proactive approach to safety data management. ✅ Advanced English Proficiency – Strong ability to
communicate effectively in international environments.