Clinical Regional Project Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regional clinical trial leader coordinating oncology studies for PSI, a contract research organization. Supervising project teams, sites, monitoring, regulatory submissions, and study milestones across designated countries.
Responsibilities:
- Oversee, manage, and coordinate clinical trial project team activities in designated countries
- Ensure consistency of Clinical Operations processes across regions
- Ensure study milestones, timelines, and subject enrollment targets are met
- Plan, implement, and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable quality-system documents
- Act as primary or secondary project management contact for project teams and PSI support services
- Review study status and provide progress reporting
- Collect and report project status updates for designated regions internally and externally
- Develop and update project planning documents, essential study documents, project manuals, and instructions
- Manage and report key performance indicators for designated countries and clinical project team members
- Coordinate study tracking systems, site contractual startup, and budget negotiations
- Establish project-team communication lines and supervise clinical project team performance
- Identify, escalate, and resolve resourcing and performance issues
- Conduct or supervise therapeutic-area training and Investigator training
- Ensure compliance with project-specific training matrices
- Perform field training of Monitors tailored to project needs
- Supervise site selection, site initiation, routine monitoring, and closeout visits
- Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution
- Supervise preparation for study audits/inspections and resolution of findings
- Coordinate supervised monitoring visits and review site visit reports
- Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications
- Oversee safety information flow and participate in feasibility research
- Review or approve project-related expenses and timesheets when delegated
Requirements:
- College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
- Prior experience in Clinical Research and on-site monitoring is required
- Prior experience monitoring within the US
- Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent is required
- Experience in Oncology is required
- Experience in GI is preferred
- Full working proficiency in English
- Proficiency in MS Office applications, including MS Project
- Communication, presentation, and customer-service skills
- Ability to negotiate and build relationships at all levels
- Team building, leadership, and organizational skills
Benefits:
- Remote work
- Career growth opportunities
- Opportunity to learn new things
- Work with a company that puts its people first
Similar Jobs
Industrial Hygienist
Industrial Hygienist managing exposure assessments and chemical safety for Jabil’s electronics and manufacturing operations. Evaluating controls, monitoring hazards, and supporting regulatory compliance across US sites.
Credit Products Specialist II – Power & Renewables
Credit Products Specialist underwriting complex Power & Renewables commercial loans for Flagstar Bank. Managing credit risk, portfolios, negotiations, and loan documentation while mentoring junior professionals.
Clinical Regional Project Lead
Regional Clinical Project Lead managing oncology clinical trials for PSI, a contract research organization. Supervising country-level teams, sites, monitoring, regulatory submissions, and study delivery.
Clinical Regional Project Lead
Regional clinical trial lead managing oncology projects for PSI, a contract research organization. Coordinating country teams, monitoring, regulatory submissions, milestones, training, and site operations.
Clinical Regional Project Lead
Clinical Regional Project Lead coordinating APAC clinical trials for PSI, a global contract research organization. Managing project teams, milestones, site operations, training, payments, and audit readiness.
Site Selection Lead
Site Selection Lead directing clinical trial site strategy and feasibility for ICON, a global healthcare intelligence and clinical research organization. Delivering compliant, high-performing site selections and activation milestones.
VBC Performance Specialist
Healthcare quality reporting consultant guiding clients through MIPS and value-based care programs at Sharecare. Analyzing performance data, ensuring compliance, and optimizing reporting outcomes.
Licensed Medicare Agent
Licensed Medicare Agents selling healthcare coverage for Chicago One Financial. Working warm leads remotely and guiding consumers through Medicare enrollment options.
Electro-Technical Officer, Maritime Operations
Electro-Technical Officer maintaining vessel electrical, electronic, and emergency power systems for F3EA maritime operations. Supporting shipboard readiness, safety, maintenance, and supervised repairs.
Tool Specialist
Emerson Professional Tool Specialist promoting RIDGID and Greenlee equipment across Orlando-area electrical, plumbing, utility, and industrial customers. Demonstrating products, training users, and driving territory adoption.
Field Service Specialist
Field Service Specialist maintaining Insightec's incisionless-surgery medical systems across the Philadelphia region. Installing, repairing, troubleshooting, and supporting systems with approximately 80% travel.
Field Service Specialist
Field Service Specialist maintaining Insightec’s incisionless-surgery medical systems across Central Florida. Installing, repairing, troubleshooting, and supporting systems with approximately 80% travel.
CX & Technology Specialist
CX technology specialist optimizing CRM, digital retail, and customer engagement platforms for Lithia & Driveway, North America's largest automotive retailer. Driving vendor performance, field adoption, reporting, and technology ROI remotely across the U.S.
Senior Evaluation Specialist
Senior Evaluation Specialist measuring adoption and impact of AI education resources for the Veterans Health Administration. Translating mixed-methods findings into recommendations for federal healthcare workforce strategy.
Performance Ads Specialist – Meta, Google
Performance Ads Specialist managing Meta and Google ad campaigns to drive ticket sales for Platinumlist.net. Hands-on execution, optimization, and analysis of digital marketing efforts.
Junior Sales Consultant
(Junior) Verkaufsberater at Carrier supporting sustainable solutions through customer acquisition and sales process. Engaging with clients to enhance innovative heating and energy solutions in a growing market.
Management and Conflict Resolution Trainer
MDA Consulting recherche un Formateur en Management et Gestion des Conflits. Le rôle implique d'animer des formations à distance et de concevoir des contenus pédagogiques.
Management and Sales Techniques Trainer
Formateur en Management et Techniques de Vente aidant les TPE et PME à développer leurs compétences. Formation à distance sur les techniques de vente et gestion des équipes.
Medical Specialist
Medical Specialist responsible for academic promotion of products in Immunology. Engaging with healthcare professionals and adhering to compliance regulations for marketing plans.