The Local Study Project Manager leads Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with IQVIA or Sponsor Procedural Documents and International guidelines such as ICF-GCP as well as relevant local regulations.
Responsible to ensure the sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, to ensure site activation, initiation and maintenance of regulatory activities for selected studies, to perform oversight of local regulatory and ethics submission packages, to oversee milestones planning and strategy for study submission, to oversee the study budget.
Main Responsibilities
• Leads Local Study Team consisting of CRAs and Study Start Up Specialists for assigned studies. Ensures, as required, the clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process with relevant stakeholders.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in applicable systems 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 Plan.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Reports study progress/update to the Global Study Associate Director/Global Study Team.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Regulatory Submissions) are set-up, updated and access is organized at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICG-GCP and IQVIA or Sponsor Procedural Documents.
• Ensures completeness of the applicable TMF system and ensures essential documents are uploaded in a timely manner to maintain “Inspection Ready” status of applicable systems.
• Plans and leads activities associated with audits and regulatory inspections in liaison with Quality Assurance.
• Oversees the execution of Site Activation and/or Maintenance for assigned studies in accordance with the agreed Start Up strategy, adhering to project timelines.
• Ensures collaboration across Regulatory and Start Up & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope.
• Provides specialist regulatory and technical scientific support to Start Up team.
• Determines regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
• Assesses and reviews the regulatory landscape and contributes to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies.
• Ensures accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
Required Skills and Qualifications
• Bachelor's Degree Life sciences or related field.
• 7 years’ relevant experience in a scientific or clinical environment. Equivalent combination of education, training and experience.
• Knowledge of Oncology therapeutical area.
• Proven work experience in Phase III studies.
• Strong negotiation and communication skills with ability to challenge.
• Excellent interpersonal skills and strong team player.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process, including site monitoring experience.
• Demonstrated proficiency in using systems and technology to achieve work objectives.
• Good regulatory and technical writing skills.
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
• Excellent understanding of study financial management.
• Proven ability to work on multiple projects balancing competing priorities.
• Very good knowledge of English language.
• Willingness to travel occasionally.
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.
