Clinical Project Manager (m/w/d), based in Germany

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 work with one single client and to manage clinical research projects in different therapeutic areas.

We currently offer the exciting opportunity to join the team as Clinical Project Manager (m/w/d) in full-time and work home-based throughout Germany.

Your responsibilities will include:

• Ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
• Keep overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Lead Local Study Team consisting of CRA(s), CSA(s), for assigned study(s).
• Lead and optimize the performance of the Local Study Team at country level ensuring compliance with SOPs, protocol, ICH-GCP and local regulations.
• Ensure, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinate the site selection process by identifying potential sites/investigators, perform initial Site Quality Risk Assessment, and conduct Site Qualification Visits to evaluate suitability and quality risks.
• Ensure timely submission of application/documents to EC/IRB at start up and for the duration of the study. Work together with Regulator Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensure timely preparation of country financial Study Management Agreement and maintain accurate study budget in clinical financial system by regular checks of the system and financial reports as agreed with Study Director.
• Ensure timely preparation of local Master CSA, including site budget, and amendments as needed.
• May contribute to onsite monitoring activities if applicable.

Qualifications:

• Master’s or higher-level degree in life science.
• Minimum of 7 years of clinical research experience in the pharmaceutical industry or CRO plus at least 2 years of local clinical trial management experience.  
• Extensive experience in feasibility is a must.
• Startup Experience: Proven track record in managing clinical projects within startup environments.
• Cardiovascular Indications (CV): Specialized knowledge in cardiovascular indications.
• Recruitment Efficiency: Understanding the importance of rapid recruitment processes.
• Influential Presence: Ability to influence and promote studies at various sites, ensuring their significance is well recognized.
• Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Fluent languages skills in German on at least C1 level and good command of English.
• Strong IT skills in appropriate software and company systems.
• Excellent decision-making and string financial management skills.
• Flexibility and ability to manage study teams in a virtual environment.
• Flexibility to business travel for meetings and site activities / around 10% of working time.

We invite you to join IQVIA!

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

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