Clinical Trial Leader (m/w/d), Single-Sponsor, Early Phase

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

As Clinical Trial Leader / Senior Clinical Trial Leader (m/w/d) you will manage cross functional teams and liaise directly between IQVIA functions and 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.

RESPONSIBILITIES

• Leading global cross-functional project team delivery, being accountable for achievement of milestones and quality of contracted scope.
• Serving as the primary contact with the customer for progress and governance.
• Developing study management plans and further documents for complex phase I trials (including protocol and protocol synopsis, possibly ICF and eCRF).
• 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,…).
• Collaborating with other functional groups within the company or 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 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 2 years of global clinical project management experience, preferable within a global CRO environment.
• Experience in set-up of phase I clinical trials including in depth knowledge of early phase study designs, clinical pharmacology and protocol writing.
• 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 languages skills in German on at least C1 level and good command of English.
• Effective communication, organizational and problem-solving skills.
• Strong leadership competencies and ability to establish and maintain effective working relationships.

We invite you to join IQVIA™.

Why join us?

Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.

Our compensation and benefits package is competitive, our scope is international, and we genuinely care about our people and their success.

We offer flexible working time and home-office.

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV, motivation letter and your certificates and reference letters.