Medical Alliance Operations Leader

Vor 5 Tagen


Basel, Schweiz FLEXSIS Vollzeit

**INTRODUCTION**:
As a preferred supplier for Roche Basel, we are looking for an individual as

**Medical Alliance Operations Leader**:
with a 12-month contract and possibility to extend. The ideal start date is asap or within your notice period. Remote/Home Office is flexible.

**ASSIGNMENT DESCRIPTION**:

- 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.

**REQUIRED PROFILE**:

- 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

**Application process**:



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