Local Clinical Project Manager

IQVIA LLC; Illkirch-Graffenstaden; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

IQVIA is a leading global provider of clinical research services, providing support to life sciences and healthcare industries. The Local Clinical Project Manager (Sponsor dedicated) will lead Local Study Teams country-wide, ensuring timely data delivery and adherence to ICH-GCP, local regulations, and Sponsor procedures.

The role may involve site monitoring, site qualifications, budget management, and regulatory submissions, with a focus on high-quality outcomes and cross-functional

Qualifications

• Bachelor degree in life science or equivalent.
• 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 cross functional teams to deliver clinical trials on time 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 handle multiple tasks with attention to detail.
• Very good knowledge of spoken and written English and French.
• Willingness to travel nationally and internationally.

Responsabilités

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s) for assigned studies.
• Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works with Regulatory 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.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including translations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports and pro-actively advises the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.

Connaissances

Cross-functional lead

Clinical PM

Budget management

ICH-GCP

CTMS usage

Bilingual EN/FR

Formation

Bachelor in Life Science

Outils

CTMS

Description du poste

The Local Clinical Project Manager (Sponsor dedicated) (m/w/d) will be leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading the Local Study Teams, the Local Clinical Project Manager (m/w/d) may perform site monitoring as needed to support the flexible capacity model. The position is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. Main Responsibilities:

Main Responsibilities:

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies.
• Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory 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.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.

Required Skills and Qualifications:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• At least a year of experience in Clinical Project Management at Local level.
• Good knowledge of Cardiovascular, Renal and Metabolic diseases, Respiratory and/or Immunology therapeutic areas.
• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Clinical Trial Phase III experience.
• Excellent understanding of the Clinical Study Process including monitoring.
• Excellent project management skills.
• Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
• Very good knowledge of spoken and written English and French language.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.