Description
One of our clients, an international company in the pharmaceutical industry currently requires a Study Delivery Lead.
Start: ASAP
Length: min. 6 months
Location: South of Brussels
Purpose of the Mission
Supports the Study Delivery Management (SDM) team for the implementation of the internal control framework, which defines the essential elements expected for compliance and risk
management. He/She will develop processes, initiatives and activities to better control the Quality of Clinical Studies/deliverables to guarantee adequate monitoring oversight of clinical studies and/or to
improve efficiency and alignment in ways of working in the Study Delivery Management group. He/She provides GCP expertise to help business to take appropriate decisions.
Primary Tasks & Responsibilities
Risk Management: Act as risk facilitator by providing practical support for reviewing and
maintenance of risk registers, assessing risks and facilitating/coordinating risk mitigation by working with risk owners.
Management Monitoring/Quality Oversight: facilitate and coordinate the deployment of
robust risk-based quality checks and quality plan.
Key Quality/Performance Indicators: Responsible for quality dashboard (eg for tracking, reporting and reinforcing adherence to plan). Take appropriate corrective measure needed.Standard Operating Procedures/Work Instructions: Serve as GCP and compliance expert
in providing input on new/existing SOPs. Ensure end-to-end cross-functional approach.
Process Improvement: Establish and maintain collaborations with partnering organizations within the company. Active participation/lead in transversal work-streams
Training: Ensure training operational excellence within Clinical Evidences Generation team by performing gap analysis for training needs, implementing learning solutions and training programs.
Support Clinical Evidences Generation Leadership Team in preparing a harmonized strategic training plan for Clinical Evidences Generation related functions.
Propose, design, and implement Risk based training programs in partnership dedicated functions.
Support development of adequate training and on-boarding tools; drive delivery of trainings according to defined strategic training plan.
Audit, Assessment & Inspection: Ensure audits, independent monitoring and inspections are adequately supported, tracked and outcomes requiring corrective action are managed in
collaboration with Quality Assurance team. Serve as CAPA Coordinator to ensure CAPA commitments are adequate, submitted and completed in a timely manner and CAPA efficiency measured.
Issue Escalation: Coordinate and support team in issue escalation and in root cause analysis.
Education/experience:
- Master Degree (or equivalent), preferably in Pharmacy, Chemistry, Bio Engineer, etc.
Medical Sciences
- A minimum of 7 years of relevant experience in clinical development and clinical operations.
Knowledge/Skills
- Good knowledge of overall clinical development process and GCP regulations
- Detail oriented
- Good communication skills
- Systematical approach to problem solving
- Proactive Flexible Sense of urgency
- Team spirit
- Well organized
- Independent worker
- Stress resistant
- Motivated and dynamic
- Experience in Risk Management, Management Monitoring/Quality oversight or training field is an
asset
- Good IT and end-user computer skills (Microsoft office)
- Excellent knowledge of written and spoken English.
Tags: Study Manager, Clinical Study Lead