Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
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.