Ensure the integrity, accuracy and compliance of clinical trial data.
-Track and report study metrics to internal and external stakeholders.
-Create or update Data Management Plan (DMP), Data Review Plan (DRP), eCRF Completion Guidelines (eCCGs) and other Data Management required study documents.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. The company is pioneering a transformational approach to treating cancer by harnessing the human immune system and is committed to continuous innovation in cell therapy.
Hold a leadership role within the study team, overseeing and guiding clinical trial activities at a country or regional level.
Ensure high-quality execution, compliance, and timely delivery while acting as a key coordination point across cross-functional teams.
Focus on leadership, mentorship, and remote oversight of monitoring practices with minimal to no site assignments and a low-travel model.
PSI is a leading Contract Research Organization focusing on delivering quality and on-time clinical trial services across various therapeutic areas. With over 25 years in the industry, it offers a balance of stability and innovation, fostering a dynamic team environment.
Develop and author Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support regulatory submissions for CE Mark.
Conduct comprehensive literature searches, review scientific data, and critically appraise literature to support clinical evaluations and risk assessments.
Manage CEP/CER timelines using project management tools and serve as a subject matter expert for R&D and broader Clinical/Medical Affairs activities.
Intuitive is a pioneer and market leader in robotic-assisted surgery, focused on expanding the potential of physicians through minimally invasive care and intelligent technology. The company fosters an inclusive and diverse team of passionate people grounded in integrity, with a strong capacity to learn and the energy to get things done, actively investing in long-term team member growth.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Drive product registrations in Asia, focusing on East and Southeast Asian countries.
Conduct regulatory assessments of formulas and labels for compliance with country-specific requirements.
Develop market-specific substantiation guidelines for claims and review marketing materials.
Niagen Bioscience uncovers the potential of NAD+ with precision science and creates solutions to help people Age Better. Our collaborative environment embodies "C.H.E.", emphasizing Character, Horsepower, and Experience.