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Precision for Medicine, a precision medicine CRO, is seeking an experienced Clinical Trial Manager to join its growing team. The role is fully remote and available to candidates in Hungary, Poland, Romania, Serbia, or Slovakia.
You will serve as the central intelligence hub for the clinical trials you manage, leading Clinical Research Associates (CRAs) and overseeing all clinical aspects of studies across multiple countries. Your responsibilities will include ensuring timeline adherence, maintaining scope, and delivering quality outcomes. The company emphasizes a consultative approach to trial management, positioning you as a valuable partner in operational delivery.
Key responsibilities include:
- Management and operational delivery of clinical elements within trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
- Successful execution of assigned trials and completion of trial deliverables
- Ensuring appropriate communication, regulatory documentation, and ongoing oversight of assigned trials through collaboration with functional team members
- Mentoring and training of team members
- Identifying challenges to study timelines and deliverables, offering creative action plans to the team and sponsor
- Leading CRAs in establishing relationships with sites for high-quality oversight of monitoring, regulatory, IP, site payment, and site correspondence activities
- Maintaining team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve high client satisfaction
The company specializes in oncology and rare diseases, combining novel clinical trial designs, operational and medical expertise, advanced biomarker and data analytics solutions, and a focus on precision medicine approaches.
Requirements:
- Bachelor's degree or equivalent combination of education and experience in a science or health-related field, including experience in oncology
- Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO, Pharma, or Biotech company in a dedicated clinical lead role
- Significant clinical trial management experience in oncology
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Availability for domestic and international travel including overnight stays
- Fluent English communication skills
- Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Demonstrated ability to develop positive working relationships with internal and external organizations
- Core understanding of medical terminology and clinical trial activities as it relates to clinical development plan execution
- Mastery knowledge of ICH-GCP, company SOPs, and regulatory guidance with ability to implement
