Senior Clinical Lead - Global CV/Metabolic Trials (Remote)

Actalent; Wilmington (NC); Remote; USD 110,000 - 124,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Paid Time Off

Job summary

Actalent is seeking a skilled Clinical Project Leader to oversee large Phase II–IV cardiovascular and metabolic trials from startup through closeout. The role functions as the operational face to sponsors, investigators, and partners, coordinating across sponsors, sites, and vendors to ensure on-time delivery and regulatory compliance.

Ideal candidates bring 7+ years of senior clinical project leadership, a strong GCP/FDA knowledge base, and a proven ability to manage multi-country, multi-site

Qualifications

• Senior-level: Clinical Project Leader III or equivalent.
• 7+ years in clinical project leadership.
• Experience with Phase II–IV trials in CRO.

Responsibilities

• Lead day-to-day operations of Phase II–IV trials from startup through closeout.
• Ensure studies stay on schedule, within scope, and compliant with protocol, GCP and regulatory requirements.
• Coordinate activities between sponsors, sites, investigators, vendors, and internal teams.
• Identify operational risks and develop practical solutions to keep projects on track.
• Drive site activation, regulatory submissions, essential document collection, and investigator readiness.
• Oversee trial progress and performance monitoring through study completion.
• Serve as primary client-facing contact for sponsors and key stakeholders.
• Lead study meetings and provide updates on timelines, enrollment, risks, and milestones.
• Build and maintain relationships with sponsors, investigators, sites, vendors, and internal teams.
• Communicate effectively with partners, managing expectations and alignment.
• Provide guidance and mentorship to junior Project Leaders and team members.
• Lead cross-functional meetings ensuring clear priorities and responsibilities.
• Contribute to study processes, workflows, and best practices.
• Monitor study performance and compliance and address issues promptly.
• Support protocol amendments and change-management activities.
• Ensure adherence to GCP, FDA regulations, and institutional policies.
• Manage complex operational logistics across multi-country trials.
• Track site startup timelines and enrollment readiness.

Skills

Clinical project leadership

Regulatory compliance

GCP knowledge

Cross-functional collaboration

Vendor management

Sponsor communication

Risk management

Education

Bachelor's degree

Job description

Actalent is seeking a skilled Clinical Project Leader to oversee large Phase II–IV cardiovascular and metabolic trials from startup through closeout. The role functions as the operational face to sponsors, investigators, and partners, coordinating across sponsors, sites, and vendors to ensure on-time delivery and regulatory compliance.

Ideal candidates bring 7+ years of senior clinical project leadership, a strong GCP/FDA knowledge base, and a proven ability to manage multi-country, multi-site