Clinical Operations Excellence Lead

The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organisation (Global Trial Operations, Data Management, Medical Writing and Global Sourcing & Alliance Management), in accordance with the global quality strategy. The successful candidate will excel in leadership and establishing good and effective internal and external working relationships and communication.

This position reports into the Head Clinical Operations Excellence. We want to fill in the position in Europe or the United States.

Roles & Responsibilities

Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents.

Identify and drive continuous improvement of processes and systems within Global Clinical Operations organisation

Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout

Drive the investigations and development of CAPA plans related to process-level non-compliances, audit and inspection findings, within the Global Clinical Operations organisation

Actively contribute to a feedback culture on non-compliance, CAPA, inspection and audit findings. Identify opportunities to share knowledge and expertise

Actively participate in defining and monitoring compliance and quality metrics to ensure compliance oversight in Global Clinical Operations processes and projects

Ensure proper focus and prioritization of clinical process improvement activities by consistently applying Quality Risk Management and Quality-by-Design principles

Identify and implement leading edge technologies and methodologies to enable quality by design of clinical study activities

Active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular review of the inspection readiness status

Lead and/or contribute to cross-functional and/or cross-company initiatives aiming to increase quality and compliance, while decreasing rework

Ensure alignment with the QA organisation

Act as interface between Global Clinical Operations and stakeholder organizations/functions in clinical development

Foster co-creative working relations with partnering organizations such as QA, BIS, Clinical Development, GPS, GRA

Skills & Competencies

Extensive experience of GCP/Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug development

Excellent interpersonal negotiation and leadership skills

Strong written and verbal communication skills, acting globally in a culturally-diverse dynamic team

Ability to act independently and effectively prioritize

Root Cause Analysis, CAPA Development and Risk Management methodology expertise

Education & Qualifications

Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience

Minimum of 10 years of experience in Clinical and/or Pharmacovigilance Quality Management

Working knowledge of the relationship and regulatory obligations of pharmaceutical/biotech companies and CROs

Global Strategic Drug Development experience

REQ-2761