"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Manager Clinical Affairs Monitoring (f/m/d)

Bad Vilbel Germany (DE) Full-time Permanent Quality Professionals

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.

• 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.

• 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.
  

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development
• Individual development and training opportunities
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
• Job ticket for the RMV region and Job Bike
• Childcare allowance
• Health-promoting offers such as or the STADA Gym (free of charge)
• Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund
• Subsidized cafeteria

We look forward to receiving your application via our . At you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to . Part-time requests are considered on an individual basis.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.