IQVIA
Clinical Project Manager
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Clinical Project Manager (Sponsor dedicated)
The Clinical Project Manager (Sponsor dedicated) 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 Clinical Project Manager may perform site monitoring as needed to support the flexible capacity model. The Clinical Project Manager is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed, and documentation archived.
Main Responsibilities
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to the 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 an 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 proactively 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.
- Organizes regular Local Study Team meetings on an agenda-driven basis.
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Required Skills and Qualifications:
- Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
- At least a year of experience in Clinical Project Management at the Local level.
- Very good knowledge of Oncology or Respiratory therapeutic area.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of the time plan, budget, and with the 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 language.
- Good ability to learn and adapt to work with IT systems.
- Ability to travel nationally and internationally as required.
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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.
Please note this role is not eligible for UK visa sponsorship.
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.
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