Global Study Manager II — Lead Global Trial Operations

Parexel; Bismarck (ND); Remoto; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking a Global Study Manager II to provide operational leadership across the study lifecycle, overseeing study management, site management, and CRO/vendor deliverables for global trials.

You will lead startup, monitoring, and budget activities, coordinate cross-functional teams, ensure inspection readiness, and mentor study operations staff. This role requires extensive GCP knowledge and international travel.

Competenze

• Minimum 7 years of operational clinical trial experience.
• Proven experience in study management and leadership.
• Experience overseeing CROs and vendors.
• Fluent in written and spoken English.
• Willingness to travel as required for global trials.

Mansioni

• Lead and coordinate global study management oversight from startup to database release.
• Provide quality oversight of regional operations and CRO tasks for study execution.
• Set recruitment targets and milestones, acting as the accountable point for study plans.
• Manage study budgets, vendor contracts, and cost variance across sites.
• Ensure inspection readiness and vendor oversight; participate in UAT and system setup as needed.
• Develop study-level plans, training, and IMs; mentor SOMs and CSTAs where applicable.
• Collaborate with CSTL and cross-functional teams to resolve site-level issues.

Conoscenze

Clinical research experience

Study management leadership

Vendor/CRO oversight

English proficiency

Travel willingness

Budgeting per subject costs

Global trial support

Formazione

BS/BA with 7+ years in clinical trials

MS/MBA with 6+ years in clinical trials

Scientific/technical degree preferred

Descrizione del lavoro

Parexel is seeking a Global Study Manager II to provide operational leadership across the study lifecycle, overseeing study management, site management, and CRO/vendor deliverables for global trials.

You will lead startup, monitoring, and budget activities, coordinate cross-functional teams, ensure inspection readiness, and mentor study operations staff. This role requires extensive GCP knowledge and international travel.