Clinical Trial Lead (m/w/d)

IQVIA

Industria farmaceutica di ricerca

20095 Milanino, Lombardia - Italien

Specialista Senior / Project Manager

Experteer Overview

In this role you will lead the operational delivery of early-phase (Phase I/II) clinical trials within a sponsor-dedicated team, ensuring milestones, quality, and financial control. You will coordinate global, cross-functional teams and serve as the primary customer contact for trial governance. You’ll craft study management plans, contribute strategic input on early development, and ensure compliance with GCP/ICH and local regulations. The position blends leadership with hands-on trial oversight, supported by domain experts and data-driven tools.

Retribuzione / Benefits

market-competitive gross annual salary (Austria)
career development opportunities
international project exposure
collaboration with domain experts
data analytics-enabled work environment
professional integrity and transparent hiring

Responsabilità

Lead global cross-functional project team delivery and ensure trial milestones and quality
Serve as primary customer contact for trial progress and governance
Develop study management plans and complex Phase I/II trial documents (protocol, synopsis, ICF, quality plan)
Make medical/scientific decisions in alignment with MD colleagues and provide strategic input for early development
Ensure consistent use of study tools, training materials, and standard processes
Lead core trial teams (data managers, statistician, pharmacokinetics, CTM, etc.)
Oversee Trial Oversight Meetings as applicable
Collaborate with client functional groups to support milestones and resolve issues
Consult with pharmacogenetics experts on preclinical/medical aspects and SAEs/SUSARs
Anticipate project risk and implement mitigation strategies

Requisiti fondamentali

Master's or higher-level degree in life sciences (MD a plus)
Minimum 5 years global clinical operations management experience (10 years for Senior CTL)
Experience in setup and conduct of Phase II trials; knowledge of early-phase designs and protocol writing; Phase I/III experience advantageous
Knowledge of GCP/ICH guidelines and local laws
Therapeutic area knowledge in respiratory, inflammatory, cardiovascular-metabolic, CNS, oncology advantageous
Strong computer skills (Word, Excel, PowerPoint)
Fluent English
Effective communication, organizational and problem-solving skills
Strong leadership and ability to build effective working relationships

Effective communication Strong leadership Problem-solving GCP/ICH regulatory knowledge Protocol writing and trial design Integrated quality plans

Descrizione della posizione

In this role you will lead the operational delivery of early-phase (Phase I/II) clinical trials within a sponsor-dedicated team, ensuring mi…

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