Lead Project Manager (Inclusion & Diversity Project)

Do you want to be part of a team with a real impact on global health?
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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. xqbhyrx

Subsidized canteen service available on-site.