Data Risk Project Lead

4 weeks ago


Canada Pfizer, S.A. de C.V Full time
Pfizer Research & Development: Driving Quality in Clinical Trials

The Asset Quality Lead plays a critical role in ensuring the quality of clinical trials by maintaining a 'quality' line-of-sight for assigned programs/protocols. With a deep understanding of GCP quality and risk management principles, this role brings expertise to asset and study teams, driving quality risk management and inspection readiness activities.

Key Responsibilities:
  • Provide input and support to asset-assigned AQLs to ensure clinical development plan strategy and asset-level risks are incorporated into study and asset-level risk management and oversight.
  • Utilize quality measures/data to monitor study quality and identify potential risks, quality trends, and support state of quality reporting.
  • Communicate key quality information across study teams and serve as GCP quality expert to study teams.
  • Monitor submission risk and flag major risks for Category Quality Head review.
Requirements:
  • A scientific or technical degree is preferred. BS or MS/MBA with proven/significant experience or equivalent.
  • Ability to build strong network/knowledge/relationships with internal/external stakeholders.
  • Advanced knowledge, experience, and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines such as quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit, and regulatory inspection process, and/or inspection readiness.
  • Experience of working on global initiatives or project teams.
  • Appreciation of diverse needs of different regulatory requirements of various sites and countries.

Pfizer, S.A. de C.V. is an equal opportunities employer. All applicants must have the relevant authorization to live and work in their home country (UK, Canada, Greece as applicable). A site-based role, our flexible working policy applies.


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