Clinical Project Manager (Sponsor Dedicated) - Kyiv

About the role

The Clinical Project Manager (sponsor dedicated) leads Local Study Teams at country level to deliver committed components of clinical studies within agreed resources, budget and timelines, in line with Sponsor Procedural Documents, ICH-GCP and local regulations. The role may also include site monitoring under a flexible capacity model, and covers the full site lifecycle from identification and qualification to initiation, monitoring, closure and archiving of documentation.

Key responsibilities

• Lead the Local Study Team of CRAs and CSAs and ensure compliance with Sponsor procedures, ICH-GCP and local regulations.
• Ensure clinical and operational feasibility assessments of potential studies are performed to the highest quality.
• Coordinate site selection, run initial Site Quality Risk Assessments and Site Qualification Visits, and oversee site setup, initiation, monitoring and closure.
• Ensure timely submission of applications and documents to EC/IRB and to regulatory authorities, working with Regulatory Affairs.
• Prepare the country financial Study Management Agreement, maintain the study budget, prepare the local Master CSA and amendments, and prepare the country-level Master Informed Consent Form and site-level ICFs, including translations.
• Collect all ICH-GCP trial documents required before study start, and plan and coordinate local drug activities.
• Set up and maintain the study in CTMS and local websites, and manage monitoring activities from activation to closure, reviewing monitoring reports and advising monitors.
• Perform co-monitoring and accompanied site visits, resolve complex study issues, and organise regular Local Study Team meetings.

Required profile

• Bachelor's degree in a related discipline, preferably life sciences, or equivalent.
• At least one year of experience in clinical project management at local level.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials on time, within budget and to required quality.
• Clinical Trial Phase III experience.
• Very good knowledge of spoken and written English and Ukrainian.
• Ability to travel nationally and internationally as required.

Required skills

• Very good knowledge of oncology or respiratory therapeutic areas.
• Excellent understanding of the clinical study process, including monitoring.
• Strong project management, prioritisation, attention to detail and negotiation skills.
• Ability to learn and adapt to IT systems.