Project Manager Country Operations

We currently have the exciting opportunity to join our FSP team in Poland as Project Manager Country Operations.

The Project  Manager Country Operations  is accountable within their region for the successful execution of study deliverables and  the quality execution of protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency in timely completion of monitoring activities.

Essential Functions

• Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
• Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations.
• Quality of monitoring oversight in the country for assigned study(ies).
• Meeting recruitment targets for assigned study(ies).
• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
• ICF customization at country/site level for the assigned studies.
• Negotiation of site study contracts and budgets for the assigned studies at country level.
• Review of local regulatory documentation and oversight of local regulatory activities.
• Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.
• Scheduling and leading effective country calls with local study team.
• Leading recruitment discussions at local level for the assigned trials.

Qualifications

• Bachelor's Degree Life sciences or related field
• Minimum 5 years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
• Communication - Strong written and verbal communication skills including good command of English and local language. Strong presentation skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Willingness to travel

Please apply with your English CV.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com