Local Study Project Manager - Sponsor Dedicated

About the role

The Local Study Project Manager leads Local Study Teams at country level to deliver committed components of clinical studies within agreed resources, budget and timelines, in line with IQVIA or Sponsor procedural documents and international guidelines such as ICF-GCP and local regulations. The role covers site identification, qualification, setup, initiation, monitoring, closure and archiving, as well as regulatory and ethics submissions, milestone planning and study budget oversight. Only candidates based in the listed location(s) will be considered.

Key responsibilities

• Lead the Local Study Team of CRAs and Study Start-Up Specialists and assess the clinical and operational feasibility of potential studies.
• Coordinate site selection, plan and coordinate local drug activities (purchase, reimbursement to destruction), and set up and maintain the study in local systems and websites.
• Oversee monitoring from site activation through closure, identify risks and resolve complex issues, and run regular Local Study Team meetings.
• Assist in forecasting timelines, recruitment, budget, materials and drug supplies, and report progress to the Global Study Associate Director.
• Ensure regulatory submissions, payments and the TMF are handled correctly, and prepare for audits and regulatory inspections with Quality Assurance.
• Determine regulatory strategy and expectations, review the regulatory landscape and provide regulatory and technical support to the Start-Up team.
• Manage site activation and maintenance, collaborate with Regulatory and Start-Up teams, and train and coach new team members on GCP and procedural documents.

Required profile

• Bachelor's degree in life sciences or a related field, or equivalent combination of education, training and experience.
• 7 years' relevant experience in a scientific or clinical environment, including proven experience in Phase III studies.
• Knowledge of the oncology therapeutic area.
• Very good knowledge of Slovak or Czech and English, and willingness to travel occasionally.

Required skills

• Thorough understanding of regulated clinical trials and the drug development process, including site monitoring experience.
• Strong knowledge of GCP and ICH guidelines, and excellent regulatory and technical writing skills.
• Excellent understanding of study financial management and ability to balance multiple projects.
• Proficiency in using systems and technology, and strong negotiation and communication skills.

The potential base pay range, annualized, is 41,600 to 62,400 EUR, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.