The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
The country Clinical Research Lead (CRL) responsibilities include operational delivery of strategic clinical studies assigned to the country, in accordance with ICH/GCP, Incyte SOPs, local operating guidelines and local requirements. The Clinical Research Lead works locally to ensure country goals for recruitment and completion of key R&D sponsor deliverables are met.
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.
- Proven experience in feasibility and study start-up.
- Fluency in German and English language
- 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.
Please apply with your English CV.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
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. Learn more at https://jobs.iqvia.com
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.
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