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About the role
Key responsibilities & impact- Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities
- Ensure clinical studies progress as planned and achieve milestones according to timelines, budget, and quality standards
- Lead and facilitate communication across functions, external partners, and service providers
- Lead and conduct investigator meetings and other study-related meetings
- Provide input into and hold accountability for essential study-level documents from Clinical Study Protocol through Clinical Study Report
- Develop and maintain study plans, quality and risk management plans, risk response strategies, and issue escalation pathways
- Oversee external service providers, including CROs, central laboratories, IXRS, and ePRO vendors
- Identify and report study quality issues and communicate corrective action plans
- Oversee Trial Master File completion and ongoing quality-control activities
- Ensure compliance with governance controls, including Delegation of Authority, Sunshine Act, financial attestations, and Clinical Trial Transparency
- Re-forecast and manage study budgets and provide budget progress reports and mitigation plans
- Ensure studies remain inspection-ready under ICH-GCP, SOPs, and relevant policies and serve as primary Study Management contact during audits or inspections
- Provide performance feedback and mentor less experienced colleagues
Requirements
What you’ll need- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- 5+ years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial Management
- Experience overseeing large global clinical trial projects
- Experience overseeing Oncology studies/projects is required
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways