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Clinical Ops Project Manager

ROLE OVERVIEW

A leading company in the pharmaceutical industry based in the Leiden area is seeking a Project Manager to oversee a follow-up paediatric clinical study. As the Project Manager, you will be responsible for ensuring the study is delivered on time, within budget, and to the highest quality standards.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Project Manager will be varied; however, the key duties and responsibilities are as follows:

1. Develop and maintain the overall project plan for the paediatric study, including timelines, milestones, budget, and resource allocation using MS Project (or equivalent).

2. Lead vendor/CRO selection, contract negotiation, management, and oversight to ensure deliverables, timelines, and quality meet expectations.

3. Manage cross-functional stakeholders, including clinical operations, regulatory, QA/RA, manufacturing/CMC, data management, and pharmacovigilance.

4. Establish and maintain Agile governance, including sprint/iteration planning, backlog management, risk/issue logs, and change control.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Project Manager, we are looking to identify the following on your profile and past history:

1. Relevant degree in Life Sciences, Pharmacy, Engineering, or equivalent.

2. Proven industry experience in clinical project management, preferably with operational experience within pharma/biotech.

3. A working knowledge and practical experience with GxP-regulated environments (GCP, GMP, GLP).

Key Words: Project Manager / Clinical Study / Paediatric / Pharma / Biotech / CRO Management / GxP Compliance / Agile Governance / Manufacturing Interface / Clinical Operations / Regulatory Affairs

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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