Clinical Project Leader
hace 4 días
Garrigàs
Do you want to be part of a team with a real impact on global health? ¿Tiene las siguientes habilidades, experiencia e impulso para tener éxito en este puesto? Descúbralo a continuación. At Noucor, a chemical and pharmaceutical company, we offer you the opportunity to lead projects that reach more than 100 countries worldwide . We are currently looking for a Clinical Project Leader to join Noucor's Clinical and Preclinical Department. Main Responsibilities As a Clinical Project Leader, you will contribute to the planning and execution of the clinical and/or preclinical development of VAM products and/or NCEs, supporting biopharmaceutical development, clinical and preclinical studies, regulatory submissions, and post-registration activities. • Design, manage, monitor, complete, and communicate planned clinical and/or preclinical studies., • Ensure that clinical trials are conducted in compliance with Good Clinical Practice (GCP) guidelines and company procedures., • Prepare, manage, and update registration-related documentation, as well as documentation arising from deficiencies identified during clinical and/or preclinical evaluation phases., • Manage information and maintain communication with external clinical and preclinical experts., • Coordinate activities required to obtain the documentation and materials necessary for conducting clinical trials involving investigational products or new therapeutic indications for marketed products (Phase I–IV studies)., • Perform all activities related to the design (drafting/reviewing protocols and other technical documentation), management (investigator selection, study medication, etc.), monitoring, and close-out (final report review and related procedures) of clinical trials., • Identify, request proposals from, and select the most suitable Contract Research Organizations (CROs) for planned preclinical studies and/or clinical trials., • Oversee and monitor clinical and preclinical studies outsourced to CROs and provide regular updates to the PM Manager., • Provide guidance and collaborate with departments and business areas involved in the preparation and/or maintenance of the product's technical dossier, including Regulatory Affairs, Pharmacovigilance, and other relevant functions. Requirements • University degree in Health Sciences, preferably Pharmacy. Degrees in Human Biology, Biotechnology, or Biomedicine will also be considered., • Minimum of 5 years of experience in clinical studies, particularly Phase II–IV clinical trials., • Minimum of 2 years of experience coordinating global clinical trials as a Clinical Project Manager or Study Manager., • Experience in preclinical studies is considered a plus., • Advanced English proficiency (C1 level)., • Strong knowledge of Good Clinical Practice (GCP) guidelines. We Offer Work within a great team of professionals with a very good work environment. Competitive benefits package and flexible schedule. Subsidized canteen service available on-site. Free parking for employees. We care about your well-being – the Wellness Plan includes physiotherapy, online psychology services, sports events, and more. Offices in Palau-solità i Plegamans. Interested in joining us? At Noucor, we believe in the value of diverse teams. xcskxlj We therefore welcome and consider all applications regardless of gender, age, background, sexual orientation, gender identity, or any other personal characteristic. If you meet most of the requirements and are motivated by the project, we would be pleased to hear from you.
