Clinical Trial Lead (m / w / d)

IQVIA; Frankfurt; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading global clinical research firm in Frankfurt seeks a Clinical Trial Leader. You will manage global project teams, ensure quality and compliance in clinical trials, and develop management plans. A Master’s degree in life sciences and 3+ years in clinical operations are required. The role requires fluency in English and advanced German skills. Join us in improving patient outcomes through innovative treatments.

Qualifikationen

• Minimum of 3 years of clinical operations management experience.
• Fluent in English and good knowledge of German (C1 level preferable).
• Understanding of GCP/ICH guidelines and local laws.

Aufgaben

• Lead global cross-functional project teams throughout trials.
• Serve as the primary contact for trial progress and governance.
• Develop study management plans and author trial protocols.

Kenntnisse

Global clinical operations management

Early phase study design

Protocol writing

Effective communication

Leadership competencies

Ausbildung

Master’s or higher-level degree in life sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Jobbeschreibung

Overview

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department isproviding highly skilled professionals to our client’s project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with early phase clinical research projects (phase I and IIa) in different therapeutic areas.

As Clinical Trial Leader (m/w/d) you will be accountable for the operational performance of the trial (preparation, initiation, conduct, close-out and reporting). As such you will manage cross functional trial teams at the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics.

Please apply with your English CV.

RESPONSIBILITIES

• Leading global cross-functional project team delivery, being accountable for trial oversight, achievement of trial milestones and trial quality.
• Serving as the primary contact within the customer for trial progress and governance.
• Developing study management plans and further documents for complex phase I and phase IIa trials (including authoring trial protocol and protocol synopsis, ICF, integrated Quality plan, etc.).
• Takes medical and/or scientific decisions (for non-medics in alignment with MD colleagues at the customer) and provides strategic input for early clinical development.
• Ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures.
• Leading (interdisciplinary) of the core trial teams (e.g.: trial data managers, trial statistician, trial pharmacokinetics and clinical trial manager,…).
• Leading the Trial Oversight Meeting (as applicable).
• Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles.
• Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs).
• Anticipating project risk and implementing mitigation strategies.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• Master’s or higher-level degree in life sciences or related field. An education as a physician would be a plus.
• Minimum of 3 years of global clinical operations management experience, preferable within a global CRO environment.
• Experience in set-up and conduct of phase I and Phase IIa clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology.
• Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines and relevant local laws.
• Therapeutic area knowledge in any of the following would be an advantage: cardiovascular - metabolic, inflammatory, CNS, oncology.
• Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.
• Fluent language skills in English and good knowledge of German at preferably least C1 level.
• Effective communication, organizational and problem-solving skills.
• Strong leadership competencies and ability to establish and maintain effective working relationships.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com