Medical Alliance Operations Leader (m/f/d)

Ihre Aufgaben:
• Process Development and Implementation: Develop, optimize, and implement clinical research processes and procedures to ensure efficient and compliant study conduct
• Process Infrastructure Development: Establish and maintain process infrastructures to support clinical research activities
• Process Oversight and Quality Management: Monitor and manage clinical research processes to ensure quality and compliance with applicable regulations and standards
• Study Team Coaching and Training: Provide guidance, training, and support to study teams to enhance their understanding of clinical research processes and regulatory requirements
• Support Inspection and Audit Preparation and Follow-up: Prepare for and support inspections and audits by regulatory authorities and other external stakeholders; manage follow-up actions as necessary
• Issue and Finding Management and Resolution: Identify, investigate, and resolve issues and findings related to clinical research processes
• Stakeholder Management and Engagement: Engage and collaborate with internal and external stakeholders to ensure smooth and effective management of clinical research activities
• Communication and Interpersonal Skills: Demonstrate strong communication and interpersonal skills to effectively convey information and build relationships with stakeholders

Ihre Qualifikationen:
• Education: minimum Bachelor level ideally in Natural/Life Sciences
• Relevant experience in pharmaceutical or medical device area
• Proven experience with ISO 14155, ISO 20916, and ISO 13485 and awareness of applicable global regulations (21 CFR 812, EU IVDR, EU MDR)
• In-depth knowledge of drug, IVD, device combination, multi-standard studies, and combined studies
• Strong skills in process development, implementation, and infrastructure development
• Excellent process oversight and quality management capabilities
• Experience in coaching and training study teams as well as strong problem-solving skills and experience with issue and finding management and resolution
• Proven track record in supporting inspection and audit preparation and follow-up
• Excellent stakeholder management and engagement skills.
• Superior communication and interpersonal skills, (business fluent English mandatory)

Ihre Vorteile:
• A very renowned company
• You will work in an international environment

Projektdauer: 12 MM+


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