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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. xqysrnh
Subsidized canteen service available on-site.