Medical Alliance Operations Leader (m/f/d)
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
Profile
- 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)
Benefits
- A very renowned company
- You will work in an international environment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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