Global Project Lead
A global clinical research organization is seeking a Global Project Lead (GPL) to oversee large, Phase III multi‑regional clinical trials (MRCTs) in gout within the rheumatology portfolio. This role will lead global operations strategy, cross‑functional delivery, and program governance for one or two Phase III studies beginning in March. Ideal for someone who thrives in fast‑paced, international project environments and has experience managing complex global trials.
Responsibilities
- Serve as the Global Project Lead for Phase III gout MRCTs, driving overall study strategy, planning, and execution.
- Lead cross‑functional global study teams including Clinical Operations, Data Management, Biostatistics, Safety, Medical, and Regulatory.
- Ensure global trial milestones are met across all regions, maintaining oversight of timelines, budget, and risk mitigation.
- Coordinate and support regional project managers to ensure aligned global execution.
- Oversee CROs, vendors, laboratories, and external partners to ensure high-quality study delivery.
- Lead global governance reporting, including KPIs, program risks, mitigation actions, and stakeholder communication.
- Maintain compliance with ICH-GCP, SOPs, and country‑specific regulatory standards.
- Present program updates to senior leadership and collaborate with Project Directors and VP‑level stakeholders.
Qualifications
- Experience leading global or multi‑regional clinical trials (MRCTs) as a Global Project Lead, Senior Project Manager, or equivalent.
- Therapeutic experience in rheumatology-preferably gout, inflammation, or autoimmune disease.
- Proven delivery of Phase II or Phase III clinical trials, preferably registrational studies.
- Strong knowledge of ICH-GCP and global regulatory expectations.
- Demonstrated ability to manage complex timelines, cross‑functional teams, and multinational operations.
- Excellent communication, problem‑solving, and stakeholder management skills.
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