Local Study Program Lead - Oncology & Phase III

IQVIA; Reading; On-site; GBP 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a Local Study Project Manager to lead Local Study Teams at country level in Reading, UK. You will drive site activation, monitoring, and regulatory submissions in line with ICH-GCP and sponsor guidelines, while managing timelines, budgets and risk across assigned studies.

The role requires 7 years of scientific/clinical experience, oncology expertise, and strong leadership to coordinate cross-functional teams.

Qualifications

• Bachelor's Degree Life sciences or related field.
• 7 years’ relevant experience in a scientific or clinical environment.
• 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.

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.

Skills

Oncology

Phase III studies

Regulatory knowledge

GCP/ICH knowledge

Negotiation

Communication

Teamwork

English proficiency

Travel flexibility

Education

Bachelor's Degree Life sciences

Job description

IQVIA is seeking a Local Study Project Manager to lead Local Study Teams at country level in Reading, UK. You will drive site activation, monitoring, and regulatory submissions in line with ICH-GCP and sponsor guidelines, while managing timelines, budgets and risk across assigned studies.

The role requires 7 years of scientific/clinical experience, oncology expertise, and strong leadership to coordinate cross-functional teams.