Medical Alliance Operations Leader

vor 2 Wochen

Basel, Schweiz ITech Consult Vollzeit

**Project**:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified **Medical Alliance Operations Leader (M/F/d).**

**Background**:
**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
- **Nice to have**:
**Reference Nr.**: 923699TP
**Role**:Medical Alliance Operations Leader (M/F/d)
**Industrie**:Pharma
**Workplace**:Basel
**Pensum: 100%**
**Start**: 01.01.2024
**Duration: 12++**
**Deadline**: 10.10.2024

**Job Type**: 80-100%

Schedule:

- 8 Hour Shift

Work Location: On the road

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