Real World Evidence Project Manager
AbbVieОписание
Real World Evidence Project Manager/ Менеджер проектов неинтервенционных исследований
Вы будете осуществлять координацию и операционную поддержку проведения неинтервенционных исследований (ретроспективных, с перспективой на проспективные) в срок, в пределах бюджета и в соответствии с регуляторными требованиями, внутренними процедурами и стандартами качества AbbVie, а также участвовать в разработке локальных процедур и инструментов планирования. Также в зоне ответственности операционная поддержка плана публикаций и медицинских операций (мониторинг и развитие ключевых метрик активности медицинского отдела). Роль предполагает кросс-функциональное взаимодействие с локальными, глобальными коллегами и партнерами.
Reporting to: Evidence Generation & Medical Operations Lead
Role Overview: This role is responsible for the coordination and operational support of development and execution of the affiliate non-interventional studies, across therapy areas, in post-marketing setting. You will operationalize non-interventional scientific research (retrospective with the outlook for prospective) within budget, timelines and quality standards and in compliance with the regulatory guidelines and AbbVie policies. You will also operationally support the publication plan and medical operations (key affiliate Medical Affairs performance metrics). You will collaborate with the affiliate therapy area teams, global colleagues and external partners.
Main Responsibilities:
Non-interventional study management
- Execute end to end delivery of non-interventional studies (planning, start-up, conduct, close out)
- Participate in development and maintenance of the local procedures and processes including SOPs, WI, tracking and planning tools
- Ensure compliance with the applicable laws and regulations, guidelines, codes of conduct, AbbVie policies and best practices
Project & risk management
- Develop and manage project plans, timelines, milestones and critical paths, ensuring on time and on budget quality delivery across multiple parallel projects
- Continuously monitor and report the study progress, risks (enrollment, financial, etc), KPI summaries and lessons learnt to the Evidence Generation & Medical Operations Lead (EG & MO Lead) and trigger corrective actions when needed
Publications:
- Provide operational support for the realization of the affiliate publication plan
Medical Operations
- Support MO&EG Lead in development and implementation Key Performance Metrics of Medical Affairs activities
Candidate Requirements:
- 3y+ experience in running non-interventional studies A to Z is a must
- At least 5y experience in clinical research project management, preferably experience running multicountry non-interventional studies
- Broad understanding of Real World Evidence concept, applications and evolution
- Proven project management excellence, ideally PMP certification
- Strong commitment to compliance and scientific quality
- Degree in health sciences (or equivalent) Medical, pharm, biological
- Fluent in English and Russian
- Advanced MS Office and digital project planning skills
- Excellent communication & organizational skills
- High adaptability, initiative and ability to work independently
- This role offers an opportunity to support EG&MO Lead make an impact on AbbVie s research and medical operations, contribute to collaborative scientific efforts and impact the local evidence generation initiatives.
If you want to be a part of a leading pharmaceutical affiliate, drive high-quality medical research, and grow professionally, we encourage you to apply!