Manager Clinical Affairs Monitoring (f/m/d)

STADA Arzneimittel GmbH
In your role as Manager Clinical Affairs Monitoring, you will be responsible for the strategic planning and execution of monitoring activities in clinical studies from phases I to IV, with a focus on bioequivalence studies. You will oversee the monitoring activities and ensure compliance with GCP standards.
What you can expect:

• You will prepare and coordinate the monitoring activities in clinical studies and supervise monitoring service providers (MSP) and contract research organizations (CROs).
• A key task of your responsibilities is the review of monitoring visit reports and clinical study documents including monitoring plans.
• You are responsible for corrective and preventive actions (CA/PA) management and follow-up with MSP and CROs.
• You prepare agreements with MSP.
• You coordinate and execute co-monitoring activities at selected clinical study centers to ensure sponsor oversight, monitoring performance and clinical study quality.
• You actively communicate with MSP, CROs and investigator teams.
• You create and review area-specific Standard Operating Procedures.
• You will be involved in audit activities at MSP and CROs.

Who we are looking for:

• You have a degree in natural sciences, pharmacy, or a related field.
• You have a strong track record with several years of experience in clinical monitoring of both multicentric patient studies and monocentric healthy subject studies either in pharmaceutical industry or in a CRO.
• You possess in-depth knowledge of regulatory requirements (GCP, ICH).
• You are familiar with the area of quality management.
• You are able to plan strategically and solve problems with a high level of attention to detail.
• You approach your tasks systematically, independently, and responsibly, and are willing to take on cross-functional tasks.You possess strong communication skills in both German and English.