Senior Global Clinical Program Lead

Azurity Pharmaceuticals - India; Raleigh (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Tuition reimbursement

Generous PTO

Annual bonus

Job summary

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, oversight, and delivery of domestic and global postmarketing trials. The role partners with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure trials are on time, within budget, and compliant.

You will oversee study-level data monitoring, manage vendor relationships, and contribute to protocol design and country/site strategy.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 8+ years in Clinical Trial/Project Management within CRO/pharma.
• Experience leading global late-phase studies and cross-functional teams.
• Proven track record managing CROs and external vendors.

Responsibilities

• Lead operational execution of late-phase trials and oversee CRO/vendors to ensure on-time delivery.
• Develop study timelines, budgets, and risk mitigation plans.
• Lead RFP activities for studies and vendors (CROs, labs, bioanalytical).
• Coordinate cross-functional study teams across Regulatory, Data Management, Safety, and Quality.
• Ensure compliance with ICH-GCP, FDA/EMA regulations; audit-ready TMF.
• Assist in trial design and protocol writing; strategic country/site selection.

Skills

ICH-GCP knowledge

FDA/EMA regulations

Clinical trial leadership

Vendor management

Cross-functional collaboration

Communication skills

Project management

Education

Bachelor's degree in Life Sciences

Job description

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, oversight, and delivery of domestic and global postmarketing trials. The role partners with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure trials are on time, within budget, and compliant.

You will oversee study-level data monitoring, manage vendor relationships, and contribute to protocol design and country/site strategy.