Remote Senior Clinical Project Leader — Cardio/Metabolic

Actalent; Durham (NC); Remoto; USD 110.000 - 124.000; Tempo integral

Resumo da vaga

Actalent is seeking a seasoned Clinical Project Leader to oversee large Phase II–IV cardiovascular and metabolic trials from startup through closeout. You will serve as the primary operational contact, driving site activation, regulatory filings, risk management, and global study execution with sponsors, investigators, and vendors.

Based in the United States with remote flexibility, you will lead cross-functional teams, ensure GCP/FDA compliance, and provide strategic guidance and mentorship to

Qualificações

• 7+ years in a Clinical Project Leader III or equivalent senior role within a CRO.
• Bachelor’s degree in a relevant field or equivalent experience.
• Extensive clinical trial management experience across Phase II–IV, multi-site and global.
• Proven leadership of Phase II–IV clinical trials.
• Strong understanding of clinical operations, study conduct, and regulatory requirements (GCP/FDA).
• Experience coordinating cross-functional teams in a matrix environment.
• Operational face to sponsors and external partners.
• Preference for candidates in or near the Eastern Time Zone.

Responsabilidades

• Lead day-to-day operations of Phase II–IV trials from startup to closeout.
• Ensure studies stay on schedule, within scope, and compliant with GCP and regulatory requirements.
• Coordinate activities between sponsors, sites, investigators, vendors, and internal teams.
• Identify operational risks and troubleshoot to keep projects on track.
• Drive site activation, regulatory submissions, essential document collection, and investigator readiness.
• Maintain enrollment readiness and protocol adherence at sites.
• Provide operational oversight and milestone reporting to clients.
• Serve as primary client-facing contact for sponsors and stakeholders.
• Lead study meetings and communicate timelines, enrollment status, risks, and milestones.
• Mentor junior team members and lead cross-functional meetings.
• Contribute to process improvements and best practices in trial management.
• Ensure adherence to GCP and FDA regulations across activities.
• Manage complex multi-country, multi-site trials.

Conhecimentos

Clinical project leadership

GCP & FDA regulations

Cross-functional collaboration

Site startup & activation

Regulatory submissions

Risk management

Vendor management

Multi-country trials

Formação

Bachelor’s degree

Ferramentas

CTMS

Descrição da vaga

Actalent is seeking a seasoned Clinical Project Leader to oversee large Phase II–IV cardiovascular and metabolic trials from startup through closeout. You will serve as the primary operational contact, driving site activation, regulatory filings, risk management, and global study execution with sponsors, investigators, and vendors.

Based in the United States with remote flexibility, you will lead cross-functional teams, ensure GCP/FDA compliance, and provide strategic guidance and mentorship to