Local Clinical Projects Lead — Country-Level

IQVIA; Illkirch-Graffenstaden; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

IQVIA is seeking a Local Clinical Project Manager (Sponsor dedicated) to lead Local Study Teams and deliver clinical study components at country level in compliance with ICH-GCP and local regulations. The role may involve site monitoring and requires strong leadership, budget oversight, and experience with Phase III trials.

Proficiency in English and French is essential, with willingness to travel nationally and internationally.

Qualifications

• Bachelor degree in life science or related field.
• At least 1 year of Local Clinical Project Management experience.
• Good knowledge of Cardiovascular, Renal and Metabolic diseases, Respiratory and/or Immunology.
• Proven ability to lead and motivate cross functional teams to deliver trials on time, within budget and with quality.
• Clinical Trial Phase III experience.
• Excellent understanding of the Clinical Study Process including monitoring.
• Excellent project management skills.
• Strong ability to prioritize and manage multiple tasks, with attention to detail and negotiation.
• Very good knowledge of spoken and written English and French.
• Good ability to learn and adapt to IT systems.
• Ability to travel nationally and internationally as required.

Responsabilités

• Lead Local Study Team at country level to ensure timely delivery of data to required quality.
• Manage site selection, site qualification visits and regulatory submissions with local teams.
• Coordinate country budget and Master CSA, MICFs, and essential documents per ICH-GCP and local regulations.
• Set up and maintain CTMS and local websites in compliance with local laws.
• Oversee monitoring activities from site activation to study closure.
• Identify risks and facilitate resolution of complex study problems.
• Organise Local Study Team meetings and co-monitoring/training visits as needed.
• Ensure timely regulatory and ethics submissions and documentation.
• Collaborate with Regulatory Affairs for submissions and inform consent forms.

Connaissances

Leadership

Cross-functional teamwork

Clinical trial management

Budget management

Regulatory knowledge

ICH-GCP knowledge

English

French

Travel readiness

Mentoring

Formation

Bachelor's degree in life sciences or related field

Description du poste

IQVIA is seeking a Local Clinical Project Manager (Sponsor dedicated) to lead Local Study Teams and deliver clinical study components at country level in compliance with ICH-GCP and local regulations. The role may involve site monitoring and requires strong leadership, budget oversight, and experience with Phase III trials.

Proficiency in English and French is essential, with willingness to travel nationally and internationally.