Clinical Trial Lead
Vor 5 Tagen
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.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 II 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.
- Master's or higher-level degree in life sciences or related field. An education as a physician would be a plus.
- Minimum of 5 years (or 10 years for Senior CTL role) of global clinical operations management experience, preferable within a global CRO environment.
- Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage.
- 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: respiratory, inflammatory, cardiovascular - metabolic, 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
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