09 ago
|
Chemo
|
Azuqueca de Henares
09 ago
Chemo
Azuqueca de Henares
In short
Position:Clinical Development
Location: Azuqueca de Henares.
Experience: 3 to 5 years in similar roles.
Want to know more??
NSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal health.
INSUD PHARMA’s activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 10,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D; centers, 12 commercial offices, and more than 35 pharmaceutical affiliates, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.
What are we looking for??
Planning, designing, organization,
supervision of conduct and reporting of clinical trial contracted to Clinical Research Organizations (CRO) to enable studies execution within the planned timelines and in compliance with current GCP and other applicable requirements. The main focus is on pharmacokinetic (PK) and bioequivalence (BE) trials. Multicenter clinical trials and phase II and III trials may also be required with the necessary support.
The challenge
Support the design and day-to-day management of clinical/preclinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others).
Prepare and maintain the appropriate documents to support clinical strategy, study rationale, and justifications, and communicate effectively with the rest of the team involved (CRA/CTA) as well as with the reporting line Team Leader/Manager.
Participate in the selection and coordination of CROs and other external vendors, and support follow-up of contracted activities to help ensure
📌 Clinical Development (Azuqueca de Henares)
🏢 Chemo
📍 Azuqueca de Henares