Global Trial Leader, Associate Director

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); On-site; USD 190,000 - 232,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. in Princeton, NJ seeks a Global Trial Leader to manage end-to-end clinical trials across regions. You will lead the Clinical Trial Team and act as the operations contact for assigned trials, guiding start-up, execution, close-out and study report finalization.

The role requires extensive study management experience, CRO/vendor oversight, and strong regulatory knowledge to ensure quality and on-time delivery in a global environment.

Qualifications

• Minimum 10 years clinical study management with at least 4 years multinational experience.
• 3+ years in therapeutic area of company focus.
• Ability to manage delegated aspects of assigned clinical trials.
• Ability to manage CROs and Clinical Study vendors.
• Bachelor’s level degree in life sciences, pharmacy or nursing.
• Robust understanding of ICH/GCP and regulatory requirements.
• Proficiency in MS Office including Word, Excel, PowerPoint.
• Strong clinical study/project management skills.
• Outstanding communication skills, both verbal and written.
• Understanding of EDC, CDMS, IRT.

Responsibilities

• Operational oversight of end-to-end clinical trial management including CRO selection for outsourced trials, start-up, execution, close-out, analysis and reporting.
• Lead CRO study team and ensure performance and timely deliverables.
• Study start up activities (e.g., site identification, feasibility, site selection, contract negotiation and CSAs).
• Define and drive study timelines and milestones with Project Management.
• Address enrolment and retention issues to keep studies on track.
• Prepare & obtain approval for clinical trial budget and changes; forecast spend.
• Plan study activities and share with stakeholders; set up tracking tools.
• Forecast IP requirements and coordinate IP requisitions.
• Train study team on trial documents, processes & SOPs.
• Oversee TMF/eTMF maintenance and study folder updates.
• Review protocols and provide operational input; oversee vendor proposals.
• Ensure in-house trial closure and archival of documents.
• Line management for assigned resources; complete trainings.
• Coordinate SAE reporting with stakeholders; manage payments.
• Follow up with sites/vendors for pending documents.

Skills

Trial management

Project management

Vendor management

Regulatory knowledge

Communication skills

EDC/CDMS/IRT

MS Office

Independent work

Cross-functional collaboration

Education

Bachelor’s degree in life sciences/pharmacy/nursing

Job description

Sun Pharmaceutical Industries, Inc. in Princeton, NJ seeks a Global Trial Leader to manage end-to-end clinical trials across regions. You will lead the Clinical Trial Team and act as the operations contact for assigned trials, guiding start-up, execution, close-out and study report finalization.

The role requires extensive study management experience, CRO/vendor oversight, and strong regulatory knowledge to ensure quality and on-time delivery in a global environment.