Country Clinical Research Lead

• Main Responsibilities
• Oversee local CRO activities, acting as Single Point of Contact for key and strategic outsourced clinical studies, to ensure corporate and country objectives are reached and potential country issues properly followed-up.
• Collaborate and liaise with Clinical Study Teams and Global Monitoring, for Sponsor’s clinical studies conducted within country, ensuring key project milestones and high quality are delivered.
• Partner with local Study Startup Specialist or Clinical Research Associates to ensure consistency and accuracy of all core documents for local EC submission (i. e. submission pack, document customization, translations, quality check).
• Act as the central point of contact for feasibilities in the country, for clinical studies when feasibilities are requested or deferred to country by Global Teams.
• Carry out top Level feasibilities, to collect key information on competitive clinical studies, marketed and non-marketed drugs, regulatory concerns, Standard of care, etc.
• Build up professional relationship with the investigators and Key Opinion Leaders.
• Support the Global Monitoring team to conduct co-monitoring and CRA assessment visits, when needed and requested.
• Act as a Site Relationship Partner for specific studies, to build and retain relationships through the lifecycle of the clinical study, to ensure an effective clinical study conduction and completion.
• Act in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
• Collaborates and interact with Medical Affairs Department, QA, Global Monitoring, clinical Study Start-Up teams, Global Clinical Trial Managers (CTMs), Global Regulatory and other as work needs.
• Required Skills and Qualifications
• At least 5 years' clinical research experience as CRA or Lead CRA or Project Manager.
• Bachelor or higher University degree in life sciences, nursing or medical background preferred.
• Demonstrated knowledge of clinical trial methodology and drug development process, related to monitoring clinical trials, GCP, SOP and country-specific regulatory requirements.
• Strong attitude to problem solving, effectively prioritize tasks and working independently.
• Effective organizational and time management skills.
• Ability to establish and maintain effective working relationships with co-workers, managers, internal and external stakeholders.
• Available for domestic and international travel, including overnight stays up to approximately 20% of the working week.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.

All information and credentials submitted in your application must be truthful and complete.

Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.

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