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Clinical Project Manager (RWE)
Posted 3 days 2 hours ago by TFS HealthScience
Regulated Activities Scientific Project Manager (non interventional studies)
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 Regulated Activities Scientific Project Manager (PM) provides support in the execution and management of Regulated Activities: ONIS (Observational and non interventional studies, NTAs (Non trial activities), External Research (IIS and ECRs) and Early Access (OOS and CUPs) projects and processes.
Responsibilities
Track status of projects along the processes Check process execution according to standard operational procedures
Follow-up on completion of pending items
Arrange, prepare and support key alignment meetings with relevant stakeholders
Support documents adminstration
Maintain Databases up to date
Support process monitoring and reporting
Qualifications
• Bachelor's degree in science related careers (pharmacy, biology, chemistry, among others).
• At least 1 years of experience working in Pharma company / healthcare consultancy
• Experience in Real World Evidence and Observational studies management
• English fluent in written, reading, speaking - work will be 100% in English
• Solid project management skills, strong time management skills, service-oriented and organized mindset
• Familiar with GxP regulated activities
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.
TFS HealthScience
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