Fortrea is recruiting an experienced Clinical Project Manager with valuable expertise in Oncology. In this role, you will ensure the successful execution of clinical studies on a local level, while maintaining high-quality standards and regulatory compliance. This position is sponsor-dedicated for a renowned pharmaceutical company.
Please note this role is for upcoming future opportunities that may arise at Fortrea.
Summary of Responsibilities
- Leading the local study teams (consisting of monitors and study administrators) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines
- Ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived
- Ensuring timely submissions of proper application/documents to Ethic Committee/Regulatory Authority.
- Close communication with global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed with global
- Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patients admission processes in coordination with the researchers; planning and taking the necessary precaution when required
- Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, Global and Local Clinical SOP’s, and the Ministry of Health Clinical Research Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision
- Participating in system/process improvement projects within global and local task groups consisting of employees from different units
Qualifications
- University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties)
- Advanced level of English
- Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions and Oncology specific)
- Project management skills
- Strong communication and negotiation skills
- Ability to prioritize and handle multiple tasks
- Basic coaching skills and good at team work
- Financial management skills
- Effective planning and organizational skills with result-oriented approach
- Stakeholder management experienceAnalytical thinking, critical reasoning ability
- Good command of MS Office applications
- No restriction to travel
- Driving License
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