# Clinical Trial Leader / Senior Clinical Trial Leader

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/XMLNAME--Senior--Clinical-Trial-Lead--m-w-d-_R1571062?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_20cc2e74-82b

## Description

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department provides highly skilled professionals who work as integrated members of client's clinical development teams. In this sponsor-dedicated role, you will combine end-to-end operational leadership with strong scientific ownership across early phase clinical research, supported by experienced specialists, technology and data-driven insights.

We are looking for a Clinical Trial Leader / Senior Clinical Trial Leader who can take clear accountability for complex Phase I Healthy Volunteer trials, lead interdisciplinary teams, and translate early-development strategy into safe, high-quality and timely study delivery.

**Your role and impact** As Clinical Trial Leader / Senior Clinical Trial Leader, you will provide leadership and direction to the core and extended trial team and serve as the central point of accountability for the end-to-end success and delivery of assigned Phase I Healthy Volunteer trials. You will independently steer preparation, set-up, initiation, conduct, close-out and reporting, ensuring that scientific objectives are translated into operationally feasible plans and delivered to defined milestones, quality expectations and financial parameters.

Beyond operational execution, you will act as a scientifically credible early-development partner. You will contribute to study design and protocol development, support dose-escalation and other key trial decisions, integrate emerging safety and PK/PD information, anticipate risks, and drive timely escalation and resolution.

**Key accountabilities**

- Lead and deliver: Provide direction to interdisciplinary trial teams and independently lead complex Phase I Healthy Volunteer studies from preparation through reporting, with accountability for participant safety, quality, milestones, timelines, operational execution and financial control.

- Shape study design and protocol strategy: Drive or substantially contribute to protocol and protocol synopsis development with clinical pharmacology, medical, statistical, pharmacokinetic and cross-functional partners.

- Guide dose escalation and data-informed decisions: Support dose-escalation strategy and decision-making by integrating emerging safety, tolerability, PK and PD information.

- Develop core trial plans and documents: Author or coordinate study protocols, and other essential trial documents.

- Plan clinical-unit and vendor delivery: Lead feasibility, clinical-unit or site selection input, recruitment and cohort planning, study schedule development, vendor strategy, supply and biosampling dependencies.

- Drive governance and trial communication: Serve as the primary trial contact for progress, risks and governance.

- Manage safety, risk, issues and escalation: Anticipate trial risks, assess impact, define risk-balanced mitigation.

- Create cross-functional alignment: Translate scientific, medical, statistical, regulatory, safety, PK/PD, biosampling and operational requirements into clear actions.

- Oversee delivery partners: Maintain effective oversight of clinical Phase I units, CROs, laboratories, vendors and outsourced services.

- Maintain quality and compliance: Ensure adherence to GCP, ICH, applicable global and local regulations.

- Use data to steer performance: Use study systems, dashboards, metrics and operational reviews to monitor study progress.

- Support critical outputs and early-development strategy: Coordinate cross-functional contributions to authority and ethics responses.

**What you bring**

- Essential: Recent Phase I Healthy Volunteer leadership: Strong, current or recent experience leading the set-up and conduct of Phase I Healthy Volunteer clinical trials.

- Essential: Early phase study-design expertise: In-depth knowledge of early phase study designs, protocol writing and clinical pharmacology.

- Essential: Scientific contribution: Demonstrated ability to contribute to study design, dose-escalation strategy, safety assessment and interpretation of PK/PD information.

- Essential: End-to-end ownership: Accountability across study preparation, set-up, initiation, conduct, close-out, reporting.

- Leadership in a matrix: Ability to inspire high-performing interdisciplinary teams.

- Risk-based delivery mindset: Proactive risk management, sound judgement.

- Communication excellence: Clear, concise and audience-aware communication.

- Regulatory knowledge: Strong working knowledge of GCP, ICH guidelines.

- Education: A Master's degree or higher in life sciences, medicine, pharmacy, pharmacology or a related discipline is preferred.

- Language and technology: Fluent English and confidence using clinical trial management systems.

## Skills

### Required
- Clinical Trial Management
- Protocol Development
- Dose Escalation
- Safety Assessment
- PK/PD Information
- GCP
- ICH Guidelines
- Clinical Pharmacology
- Study Design

### Nice to have
- Oncology
- Inflammatory Diseases
- Cardiovascular
- Renal and Metabolic Indications
- Inspection Readiness
- Vendor Oversight
- Financial Management

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/XMLNAME--Senior--Clinical-Trial-Lead--m-w-d-_R1571062?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)