Clinical Research Manager
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
The Clinical Research Manager is responsible for certain aspects of project
activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
Key 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.
- Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers.
- Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol.
- 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,
- Advanced English,
- Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions and Oncology specific)
- CAR-T experience is a plus
- Financial management skills,
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
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