Medical Alliance Operations Leader.

On behalf of our client, we are seeking a highly motivated and experienced Medical Alliance Operations Leader to join their team. In this role, you will be responsible for overseeing the development and implementation of clinical research processes for drugs and devices, ensuring compliance with regulatory standards and requirements.

General Information:

• Start date: asap/01.11.2024

• latest Start Date: 01.01.2025

• Planned duration: 12 months

• Extension: likely

• Workplace: Basel

• Workload: 100%

• Remote/Home Office: flexible

• Working hours: Standard

Tasks & 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.

Must Haves:

• Education: minimum Bachelor level ideally in Natural/Life Sciences
• Minimum 3 to 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.
• Strong problem-solving skills and experience with issue and finding management and resolution.
• Excellent stakeholder management and engagement skills.
• Superior communication and interpersonal skills.
• Business fluent in English

If you meet the qualifications and are excited about the opportunity to make a meaningful impact in clinical research, we encourage you to apply.