Clinical Project Manager, Sponsor dedicated

-Croatia based, responsible for Croatia and Serbia-

When you join IQVIA Zagreb as a Sponsor dedicated CPM, you will start an amazing career journey, working with a highly reputable Sponsor with strong portfolio. The role is primarily accountable for the end to end performance and project management for assigned protocols, in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Essential Functions:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• If delegated can sign contracts and manage budgets.
• Collaborates with HQ functions and locally with PV, Regulatory and GMA to align on key decisions.
• As a customer-facing role, this position will build business relationships and represent the company with Investigators.
• Shares protocol-specific information and best practices across countries\clusters.

Qualifications:

• Bachelor's Degree in Life sciences.
• Relevant Clinical Project management experience with previous CRA experience and preferably Oncology management experience.
• Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.
• Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
• Understanding of project financials including experience managing, contractual obligations and implications.
• Ability to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback.
• Ability to make decisions, organize resources needed to accomplish tasks, set objectives, and provide clear direction to others.
• Attention to detail and accuracy in work. Results-oriented approach to work.
• Openness to learning and keeping own knowledge and skill set current and evolving.
• Strong communication, problem solving and presentation skills.
• Fluency in both Croatian and English language.
• Tech savvy.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Available to travel within dedicated countries.

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