Trial Delivery Manager, Sponsor Dedicated

Key Responsibilities

• Global & Regional Trial Leadership – Lead and coordinate global and regional clinical trial management activities for internally managed and outsourced studies. Serve as a core member of the Trial Team, partnering with Global Leadership to deliver operational strategy and execution. Act as primary point of contact for country, regional, and functional stakeholders within Clinical Development Operations. Function as backup or first point of contact in the absence of the Global Leadership.
• Central Trial Oversight & Execution – Drive trial delivery across the full lifecycle: feasibility, site selection, start-up, execution, and close‑out. Ensure milestones, timelines, and deliverables are met and transparently communicated. Maintain real‑time trial oversight through dashboards, reports, and issue tracking. Act as the central subject matter expert for assigned protocols.
• Vendor & Partner Management – Provide oversight of CROs and global vendors supporting site‑facing activities, including: IWRS/IVRS, Central Laboratory ePRO/eCOA, Imaging, Translation and printing, Ancillary supplies and investigator meetings. Review and approve vendor deliverables, invoices, and spend. Ensure vendor performance aligns with trial plans, budgets, and quality expectations.
• Quality, Compliance & Inspection Readiness – Ensure continuous inspection readiness in accordance with ICH‑GCP, applicable regulations, and sponsor SOPs. Lead or contribute to CAPA development and resolution. Support Health Authority inspections, internal audits, and quality reviews. Partner with Quality & Compliance stakeholders to ensure effective oversight.
• Enrollment, Feasibility & Risk Management – Lead feasibility activities and provide data‑driven recommendations. Establish and track regional enrollment commitments, ensuring alignment with projections. Ensure robust recruitment and contingency plans are in place. Proactively identify risks, elevate issues, and drive resolution.
• Documentation, Systems & Trial Deliverables – Oversee trial documentation, filing, archiving, and retention. Create, review, and maintain trial‑specific documents, including:
  Monitoring Guidelines, Informed Consent Forms, IMP and blinding documentation, Feasibility and site selection materials. Support HA/EC/IRB submissions with required central documents. Coordinate data cleaning activities to support timely database lock.
• Leadership, Mentorship & Continuous Improvement – Lead teams across projects or programs. Provide coaching and mentoring to less experienced team members. Lead or participate in special initiatives, task forces, and process improvement efforts. Contribute innovative ideas to enhance operational efficiency and quality across the FSP partnership.

Base Level – Independently manages complex trials with limited oversight. Demonstrates strong operational leadership and stakeholder management. Owns central trial oversight activities and delivers consistent, high‑quality results.

Advanced Level – Leads program‑level or high‑impact trials with increased complexity. Manages and mentors multiple team members across insourced and outsourced studies. Serves as a Therapeutic Area Expert or Functional Champion, influencing strategy and best practices. Proactively identifies and resolves budget, resourcing, and operational risks.

• Education – Bachelor’s degree (or equivalent) in Life Sciences (e.g., Biology, Chemistry, Nursing, Pharmacy).
• Base – 6+ years of clinical trial management experience in pharma and/or CRO environments.
• Advanced – 8+ years of clinical trial management experience, including leadership of complex global studies.
• Proven experience managing trials from start‑up through…