Clinical Trial Manager - Single Sponsor dedicated (m/w/d)

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

We currently offer the exciting opportunity to join the team as Clinical Trial Manager (m/w/d) in full-time and work home-based throughout Germany. In this role you will be accountable for the operational management of the component of clinical trials. Furthermore, you will need to gain an oversight to assure achievement of trial recruitment commitment, timelines, budget and quality standards.

MAIN RESPONSIBILITIES

• Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the local level.

• Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders and trial team members at a local level.
• Manage orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.

• Responsible for managing the planning, implementation and tracking of the clinical trial process as well as risk mitigation.

• Work within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.
• Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals.
• Ensure compliance with ICH-GCP and all other relevant regulatory regulations.
• Assure highest ethical and professional standards, patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements.
•  Responsible for development and implementation of country level engagement plans, recruitment planning and risk mitigation.
• Assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
• Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan.
• Develop and maintain relationships with investigational sites and support CRAs in site contacts.

• Support Clinical Trial Lead during investigator meetings.
• Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
• Master’s or higher-level degree preferable in life science.
• Long term experience in clinical research, including at least 2 years of clinical trial management experience.

• Knowledge of Oncology, Idiopathic Pulmonary Fibrosis (IPF) and/or Interstitial Lung Disease (ILD) therapeutic areas is preferred.
• Exceptional knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Effective communication skills, fluent languages skills in German (at least C1 level) and very good command of English.
• High organizational and planning skills, time management and prioritization skills while working on multiple projects.
• Excellent leadership and collaboration skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to influencing business partners in matrix structures.
• High degree of self-accountability and commitment and a strong growth mindset to drive change and contribute actively to future leading transformation.
• Very good computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Flexibility to occasional business travel for client meetings.
• Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.