Clinical Operations Manager

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz Actalent Vollzeit

Company Overview

We are Actalent, a leading provider of clinical project management services.

Main Activities and Key Responsibilities:

  1. Act as the primary point of contact for Vendor and Third-Party Management.
  2. Coordinate activities and responsibilities with Evidence Generation study teams (Study Execution + Evidence Generation).
  3. Serve as a central point of coordination with Evidence Generation teams.
  4. Oversee the end-to-end process, including liaison with Legal, qualification, RFP, contracting, and PO management.
  5. Interface with stakeholders and relevant functions, providing inputs and updates as needed.
  6. Manage qualification project timelines and proactively alert stakeholders to deviations or risks.
  7. Coordinate the steps for third-party (vendors and non-vendors) due diligence and/or qualification activities as required.
  8. Ensure oversight, completion, and management of third-party due diligence and qualification activities.
  9. Provide support and contribute to the third-party Quality Risk Assessment activities (QRAs).

Background:

  1. Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
  2. Project management experience in clinical operations in a pharmaceutical company or a contract research organization.
  3. Good knowledge of regulatory requirements in Clinical Research and drug development.
  4. Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
  5. A broad understanding of main Health Authorities standards (e.g., FDA, EMEA) and ICH regulations and guidelines.
  6. Understanding of procurement processes and knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA, and new technologies).
  7. Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes.

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