Remote Clinical Trial Lead - Oncology Studies

Menarini Group; New York (NY); Remote; USD 218.000 - 250.000; Vollzeit

Zusammenfassung

Menarini Stemline is seeking a Clinical Trial Lead to plan, execute and oversee designated clinical studies from initiation to closure. This role is remote in the US, requiring strong governance of timelines, quality standards, and budget commitments.

The successful candidate will lead cross-functional teams, manage CROs and vendors, and ensure regulatory compliance across Phases I–III, with extensive experience in oncology/hematology trials.

Qualifikationen

• Experience in clinical research with sponsor company or CRO (oncology/hematology).
• Advanced understanding of clinical development within Phases I–III.
• Able to independently manage multiple clinical studies.
• Excellent knowledge of ICH/GCP and FDA CFR.
• Able to communicate effectively.

Aufgaben

• Develops study documents including protocols and informed consent templates.
• Coordinates CROs and vendors to ensure quality and contract alignment.
• Oversees study start-up activities and regulatory filings for sites.
• Leads study management team meetings and cross-functional collaboration.
• Maintains eTMF and participates in audits/inspections.
• Supports trial budget tracking and invoice approvals.

Kenntnisse

Study management

Vendor management

Leadership

Regulatory knowledge

Communication

Ausbildung

BA/BS or equivalent degree

Oncology/Hematology experience preferred

Jobbeschreibung

Menarini Stemline is seeking a Clinical Trial Lead to plan, execute and oversee designated clinical studies from initiation to closure. This role is remote in the US, requiring strong governance of timelines, quality standards, and budget commitments.

The successful candidate will lead cross-functional teams, manage CROs and vendors, and ensure regulatory compliance across Phases I–III, with extensive experience in oncology/hematology trials.