Global Clinical Trial Lead, Operations & Strategy

Sun Pharmaceutical Industries; Princeton (NJ); On-site; USD 151,000 - 184,000; Full time

Job summary

Sun Pharmaceutical Industries in Princeton, NJ seeks a Global Trial Leader to oversee trial management end-to-end, lead the Clinical Trial Team, and serve as the clinical operations contact for assigned trials.

You will drive start-up, execution, close-out, budget planning, vendor management, and regulatory compliance across global or regional studies, collaborating with cross-functional teams to ensure quality and timely delivery.

Qualifications

• Minimum 10 years clinical study management experience with at least 4 years direct multinational study management experience.
• 3+ years in therapeutic area of company's focus.
• Ability to manage delegated aspects of assigned clinical trials.
• Ability to manage CROs and Clinical Study vendors.
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
• Proficiency in MS Office including Word, Excel, PowerPoint and other applications.

Responsibilities

• Provide end-to-end operational oversight of clinical trials, including CRO management, start-up, execution, and close-out.
• Review study documents and lead optimization of key study documents (e.g., informed consent, CRFs).
• Lead site identification, feasibility, site selection, and regulatory submissions.
• Define and drive study timelines and budgets with cross-functional teams.
• Oversee vendor performance and study milestones; forecast IP requirements.
• Ensure regulatory and GCP compliance; coordinate TMF/eTMF maintenance.
• Lead training for study teams and manage project finances and payments.
• Meet investigators and key opinion leaders; drive subject recruitment.

Skills

Clinical trial management

Communication skills

MS Office proficiency

Independent working

EDC/CDMS/IRT knowledge

Education

Bachelor's degree in life sciences, pharmacy or nursing

Tools

MS Office

Job description

Sun Pharmaceutical Industries in Princeton, NJ seeks a Global Trial Leader to oversee trial management end-to-end, lead the Clinical Trial Team, and serve as the clinical operations contact for assigned trials.

You will drive start-up, execution, close-out, budget planning, vendor management, and regulatory compliance across global or regional studies, collaborating with cross-functional teams to ensure quality and timely delivery.