Clinical Research Coordinator
Vor 7 Tagen
We are a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and a presence in around 150 countries. Our mission is to develop and commercialise medicines that serve people living with common diseases, as well as those living with some of the rarest conditions.
The Clinical Trial Liaison Manager (CTLM) plays a critical role in ensuring the successful conduct of clinical trials. As an ambassador for Recordati, you will be responsible for overseeing site and country trial delivery and performance, including subject recruitment, adherence to protocol and regulations, and timely delivery of high-quality data.
You will work closely with cross-functional project teams to ensure adherence to project plans, applicable regulatory, GCP and SOP requirements, and company policies and procedures. Your expertise will be invaluable in driving enrolment at the Principal Investigator level and facilitating collaboration between different departments or groups within the same trial site.
Key Responsibilities:
- Act as an ambassador for Recordati, supporting its positioning as a sponsor of choice.
- Drive enrolment at the Principal Investigator level and work closely with CRAs and Site Coordinators to ensure they understand the PI's enrolment strategy.
- Facilitate collaboration between different departments or groups within the same trial site to optimise the enrolment of trial subjects.
- Oversee and track patient recruitment for sites and pro-actively identify ways to prevent recruitment delays.
- Ensure data quality and data integrity meet GCP and local regulations through data review (remote and onsite).
- Conduct Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring by the CRO and study progress visits to trial sites.
- Maintain accountability for long-term operational partnerships with key sites, providing local intelligence.
- Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the Lead CSM, CSM vendor/CRO or Local CSM.
Required Education: Bachelor's degree (or international equivalent) in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background.
Required Skills and Experience:
- Understand the healthcare therapeutic landscape, patient pathways, and investigative sites.
- Excellent communication and presentation skills, with relationship management of multiple stakeholders, internally and externally.
- Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority.
- Highly developed organisational skills, problem-solving, analytical, and able to prioritise.
- Experience with tools and systems for managing clinical studies.
Travel Required: Approximately 20%.
We believe in creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
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