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Senior Manager Clinical Study Lead (Oncology), Dublin
Location: Dublin, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 5ce88ccd4145
Job Views: 7
Posted: 10.08.2025
Expiry Date: 24.09.2025
Job Description:
This role is an onsite position in one of our office locations. Fully remote is not eligible.
The Senior Clinical Study Lead (CSL) is responsible for the global execution of large and/or complex clinical trials, from design through close-out. The role requires high independence, accountability for study timelines, budget, and compliance with SOPs and ICH/GCP standards. It applies to both internally sourced studies and outsourced studies, with a varying degree of direct leadership and oversight. The position also involves driving process improvements.
Key Responsibilities:
* Lead cross-functional study teams responsible for clinical study delivery
* Develop and oversee study documentation including CRFs, data management plans, monitoring plans, etc.
* Manage study systems setup and maintenance (CTMS, TMF, etc.)
* Ensure compliance with clinical trial registry requirements
* Identify outsourcing needs and manage vendor engagement and contracts
* Contribute to budget and timeline development and management
* Lead risk assessments and mitigation strategies
* Conduct feasibility assessments and oversee site evaluation and selection
* Lead investigator meetings and monitor site activation and visits
* Develop and oversee patient recruitment and retention strategies
* Monitor data entry, query resolution, and study metrics
* Manage budgets and scope changes for studies
* Oversee clinical supplies forecasting and reconciliation
* Escalate issues and develop corrective actions
* Ensure study progress aligns with timelines, deliverables, and budgets
* Review data quality and compliance metrics
* Coordinate with CROs and vendors to ensure scope adherence
* Prepare for audits and inspections, support CAPAs
* Manage study close-out activities
* Contribute to clinical study report writing and lessons learned
* Assign tasks to management staff and support their performance
* Drive process improvements and innovative approaches in clinical studies
* May perform unmasked tasks related to investigational products and data oversight
* Supervise CTM staff, including performance management and staff development
Qualifications:
* Exceptional interpersonal and leadership skills
* Advanced expertise in clinical trial operations and strategic guidance
* Strong data-driven planning, execution, and problem-solving skills
* Excellent communication skills (verbal, written, presentation)
* Proactive, disciplined, and deadline-oriented
* Effective stakeholder influence and negotiation skills
* Knowledge of industry trends and regulatory guidelines
* Proficiency in trial management systems and MS Office applications
* Extensive experience in global clinical trial operations
* Bachelor’s degree with at least 8 years of relevant experience
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