Medical Alliance Operations Leader

Responsibilities:

• 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.

Requirements:

• Education: minimum Bachelor level ideally in Natural/Life Sciences
• 5 years of relevant experience in pharmaceutical or medical device area
• Proven experience with ISO 14155, ISO 20916, and ISO 13485
• In-depth knowledge of drug, IVD, device combination, multi-standard studies, and combined studies
• Awareness of applicable global regulations (21 CFR 812, EU IVDR, EU MDR).
• Strong skills in process development, implementation, and infrastructure development.
• Excellent process oversight and quality management capabilities.
• Experience in coaching and training study teams.
• Proven track record in supporting inspection and audit preparation and follow-up.