Medical Alliance Operations Leader

vor 2 Monaten

Basel, Schweiz FLEXSIS Vollzeit
EINFÜHRUNG:
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.AUFGABENBESCHREIBUNG:
  • 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.
ERFORDERLICHES PROFIL:
  • 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 processInterested? Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English, along with your degree certificate and latest reference letter.

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