Local Study Lead — Clinical Trials & Regulatory

Iqvia; England; Sur place; GBP 70 000 - 100 000; Plein temps

Résumé du poste

IQVIA, a leading global provider of clinical research services, is seeking a Local Study Project Manager to lead Local Study Teams and ensure delivery of clinical study components within agreed resources, budgets and timelines in line with ICF-GCP and sponsor procedures.

You will oversee site activation, regulatory submissions, monitoring, and maintenance at country level, coordinate with regional teams, and help forecast timelines and budgets.

Qualifications

• Bachelor's degree in life sciences or related field.
• 7 years' relevant experience in a scientific or clinical environment.
• Knowledge of Oncology therapeutic 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 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.

Responsabilités

• Leads Local Study Team consisting of CRAs and Study Start Up Specialists for assigned studies.
• Coordinates the site selection process with relevant stakeholders.
• Plans and coordinates applicable local drug activities (from local purchase to drug destruction).
• Sets up and maintains the study in applicable systems at study country level and local websites as required by local laws.
• Oversees, manages and coordinates monitoring activities from site activation through study closure.
• Proactively identifies risks and facilitates resolution of complex study problems.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Reports study progress to the Global Study Associate Director/Global Study Team.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures systems for Regulatory Submissions are set-up and accessible at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new Local Study Team members for compliance.
• Ensures completeness of the TMF system and timely upload of essential documents.
• Plans and leads audits and regulatory inspections with QA.
• Oversees Site Activation and/or Maintenance per Start Up strategy and timelines.
• Ensures collaboration with Regulatory and Start Up & Site Activation across regions and countries.
• Provides regulatory and technical scientific support to Start Up team.
• Determines regulatory strategy/expectations and submission parameters.
• Assesses regulatory landscape and disseminates regulatory intelligence for assigned studies.
• Maintains internal systems, databases, tracking tools, timelines and project plans.

Connaissances

Project management

Regulatory knowledge

Clinical operations

GCP/ICH knowledge

Team leadership

English proficiency

Formation

Bachelor's Degree Life sciences or related field

Outils

CTMS

eTMF

Description du poste

IQVIA, a leading global provider of clinical research services, is seeking a Local Study Project Manager to lead Local Study Teams and ensure delivery of clinical study components within agreed resources, budgets and timelines in line with ICF-GCP and sponsor procedures.

You will oversee site activation, regulatory submissions, monitoring, and maintenance at country level, coordinate with regional teams, and help forecast timelines and budgets.