Senior Phase I Trial Leader - End-to-End

IQVIA Argentina; Wien; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

IQVIA Clinical Functional Service Partnerships is seeking a Clinical Trial Leader / Senior Clinical Trial Leader to take accountability for Phase I Healthy Volunteer trials, lead interdisciplinary teams, and translate early-development strategy into safe, high-quality study delivery.

You will provide leadership from preparation through close-out, shaping study design with medical and regulatory partners, guiding dose-escalation decisions, and delivering results on time and within budget.

Qualifikationen

• Recent Phase I Healthy Volunteer leadership with end-to-end accountability.
• Expertise in early phase study design, protocol writing and clinical pharmacology.
• Ability to contribute to dose-escalation decisions and PK/PD interpretation.
• Strong cross-functional collaboration across medical, statistics, pharmacokinetics, biosampling and operations.
• Independent ownership of preparation through reporting and governance.

Aufgaben

• Lead complex Phase I Healthy Volunteer trials end-to-end.
• Prepare, initiate, conduct, close-out, and report trial activities.
• Develop study designs and protocol strategies with clinical pharmacology, medical and statistical partners.
• Guide dose-escalation decisions using safety and PK/PD data.
• Oversee vendor delivery, site selection, scheduling and budgets.
• Maintain quality, safety and regulatory compliance across the trial.
• Communicate study status to governance forums and stakeholders.

Kenntnisse

Phase I leadership

Protocol design

PK/PD interpretation

Cross-functional leadership

Risk management

Regulatory knowledge

Communication

English fluency

Ausbildung

Master’s degree or higher in life sciences/related

Tools

CTMS

eTMF

Jobbeschreibung

IQVIA Clinical Functional Service Partnerships is seeking a Clinical Trial Leader / Senior Clinical Trial Leader to take accountability for Phase I Healthy Volunteer trials, lead interdisciplinary teams, and translate early-development strategy into safe, high-quality study delivery.

You will provide leadership from preparation through close-out, shaping study design with medical and regulatory partners, guiding dose-escalation decisions, and delivering results on time and within budget.