Manager, Study Start Up

About the role

Emerald Clinical Trials is seeking a Manager, Study Start Up to lead and scale its centralised start‑up function worldwide. The role will oversee end‑to‑end start‑up activities, drive operational excellence and support business development across multiple therapeutic areas.

Key responsibilities

• Provide line management, coaching and performance management for the global start‑up team.
• Define and implement the overall start‑up strategy aligned with global and regional objectives.
• Oversee feasibility assessments, regulatory submissions, ethics approvals and site activation timelines.
• Drive process optimisation, best‑practice adoption and KPI monitoring to improve efficiency and quality.
• Collaborate with Business Development and Proposals teams on bid defenses and feasibility inputs.
• Act as a primary client stakeholder to ensure clear start‑up expectations and delivery.
• Partner with Clinical Operations, Regulatory Affairs, Project Management and external vendors.
• Ensure compliance with ICH‑GCP, local regulations and company SOPs.

Required profile

• Proven experience leading global study start‑up teams in a CRO or similar environment.
• Strong understanding of clinical trial start‑up processes, including feasibility, regulatory and ethics submissions.
• Demonstrated ability to develop and execute strategic plans and drive continuous improvement.
• Excellent communication and stakeholder‑management skills.

Required skills

• Knowledge of ICH‑GCP guidelines and regulatory requirements.
• Familiarity with clinical trial management systems and SOPs.