Clinical Project Manager

Overview

In this role you lead Local Study Teams at country level to deliver study commitments on time and with quality, aligning with Sponsor procedures and ICH-GCP. You will oversee site identification, qualification, setup, monitoring and documentation, while collaborating with Regulatory Affairs, CROs and cross-functional partners. The position involves local regulatory submissions, budgeting, and CTMS setup, with potential site monitoring to support a flexible capacity model. You drive risk management and ensure compliant execution of country-level trials.

Responsibilities

• Own country-level study commitments and timeliness of data delivery
• Lead Local Study Team (CRA/CSA) for assigned studies
• Ensure compliance with Sponsor procedures, ICH-GCP and local regs
• Coordinate site selection, Site Quality Risk Assessments and Site Qualification Visits
• Oversee regulatory submissions to EC/IRB and Regulatory Authorities during the study
• Prepare and maintain country-level budgets and Master CSA and MICF
• Prepare country-level MICF and site ICFs, including translations
• Ensure collection of essential ICH-GCP documents prior to study start
• Plan local drug activities (purchasing, reimbursement, destruction)
• Set up and maintain study in CTMS and local websites
• Oversee monitoring activities from activation to study closure
• Review monitoring visit reports and advise monitors on issues
• Co-monitoring and accompanied visits with CRAs
• Identify risks and drive resolution of complex study problems
• Organise regular Local Study Team meetings

Key requirements

• Bachelor degree in related discipline, preferably life science
• At least 1 year of local Clinical Project Management experience
• Strong knowledge of Oncology or Respiratory therapeutic areas
• Proven ability to lead cross-functional teams to deliver trials on time, within budget and with quality
• Clinical Trial Phase III experience
• Excellent understanding of Clinical Study Process including monitoring
• Excellent project management skills
• Strong ability to prioritize, multitask, detail-oriented, and negotiate
• Proficiency in English (speaking and writing)
• Ability to learn and adapt to IT systems
• Ability to travel nationally and internationally
• Location restrictions: candidates must be based in listed location(s); UK visa sponsorship not available

• leadership
• cross-functional collaboration
• negotiation
• ICH-GCP compliance
• Site qualification and monitoring processes
• CTMS usage

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