The company
Our client is an innovative biotechnology organisation focused on developing transformative treatments for patients with serious diseases. The organisation operates in a highly regulated clinical research environment and is committed to maintaining high standards of patient safety, data integrity, and clinical trial quality.
Role Description
We are looking for an experienced Clinical Trial Operations Manager to lead and coordinate clinical trials in a complex, cross-functional environment. In this role, you will oversee trial execution in collaboration with internal Clinical Management Teams (CMTs), Contract Research Organisations (CROs), and other external partners.
Responsibilities
- Lead the cross-functional, trial-specific Clinical Management Team (CMT), including CROs, to ensure clinical trials are delivered within agreed timelines and budgets and in accordance with quality standards.
- Coordinate internal and external stakeholders to support effective collaboration, communication, and progress throughout the clinical trial lifecycle.
- Contribute to CRO selection, define scopes of work, and manage ongoing CRO performance and deliverables.
- Monitor trial progress, identify potential issues, and escalate risks or concerns appropriately to maintain trial quality and timelines.
- Ensure clinical trial activities comply with applicable regulations, internal Standard Operating Procedures (SOPs), and ICH-GCP guidelines.
- Participate in audits and inspections, coordinating follow-up activities and ensuring timely responses to findings.
- Maintain and update trial budgets, including financial forecasting, accruals, and invoice management.
- Proactively assess and manage risks related to clinical trial conduct, with particular attention to patient safety and data integrity.
- Oversee trial documentation and support the maintenance of accurate, complete, and inspection-ready clinical trial records.
- Drive accountability across the CMT and external partners to ensure milestones, deliverables, and quality expectations are met.
Requirements
- Bachelor's or Master's degree in a relevant field; a Master's degree is preferred.
- At least 5 years of experience in clinical operations.
- Significant experience leading and managing clinical trials within the pharmaceutical, biotechnology, or clinical research industry.
- Demonstrated experience coordinating clinical trial activities, maintaining trial documentation, and managing CRO relationships.
- Experience with clinical trial budget monitoring, financial forecasting, accruals, and invoice management.
- Good understanding of clinical trial regulations, ICH-GCP guidelines, and quality requirements.
- Experience with risk management, patient safety, data integrity, and audit or inspection readiness.
- Strong project management, organisational, and problem-solving skills.
- Excellent communication and stakeholder-management skills, with the ability to coordinate cross-functional teams and external partners.
- A proactive, structured, and quality-focused approach, with the ability to manage multiple priorities and resolve issues effectively.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59242
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