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Clinical Systems Project Manager - Contract - Cambridge, MA

̽»¨ºÏ¼¯ is seeking an Interactive Response Technology (IRT) Project Manager to support the operational execution of IRT systems for clinical studies. This role is crucial in ensuring patient safety and data integrity by leading the setup and testing of IRT systems in compliance with GxP regulations. You will collaborate with various teams to maintain system functionality throughout its lifecycle and drive process improvements.

The Clinical Systems Project Manager will:

• Lead the setup and maintenance of IRT systems, ensuring compliance with study protocols and regulations.
• Collaborate with Clinical Operations and Quality System & Compliance teams to meet compliance requirements.
• Work with Investigational Supply Operations to ensure appropriate stock levels of investigational products.
• Support integration of IRT with Electronic Data Capture systems.
• Develop resources such as an IRT Playbook and act as the primary contact for IRT vendors.
• Implement process improvements and keep teams informed of industry trends.
• Advise on clinical study protocol development, focusing on drug attributes and IRT optimization.
• Oversee IRT vendor selection and performance management.
• Provide guidance and training on IRT systems and study medication handling.
• Ensure compliance with SOPs, GCP, ICH guidelines, and legal standards.

Skills & Requirements:

• Strong knowledge of clinical study management and IRT systems.
• Familiarity with GCP and GMP guidelines.
• Excellent project management, communication, and presentation skills.
• Bachelor's degree or equivalent; advanced degree preferred.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

̽»¨ºÏ¼¯ is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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