Local Sr Clinical Trial Manager - Fsp - InmunologyLocation: Madrid, Community of Madrid, ES
Services Overview: Local Trial Management services provide local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.
Key Responsibilities:
* Partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM), and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
* Ensure local/country team meets recruitment targets with high-quality data on time and within study budget.
* Act as the primary company contact for assigned trial at the country level and may attend/participate in Investigator Meetings as needed.
* Drive study compliance by maintaining and updating trial management systems and using study tools and management reports available to analyze trial progress.
* Contribute to site-level recruitment strategy and contingency planning in partnership with other functional areas.
* Deliver competent vendor management at the country level to support the study.
* Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training as needed.
* Ensure trial subject safety by reporting all AEs/SAEs/PQCs within the required timelines.
* Maintain complete, accurate, and timely data and essential documents in systems utilized for trial management.
* Ensure accurate finance reporting and trial delivery within budget by adhering to finance reporting deliverables and timelines.
Qualifications:
* Bachelor's Degree in Life Sciences or related field.
* 2 years of local trial management or mutually agreed clinical trial experience (3 to 5+ years preferred).
* Strong experience in Inmunology studies.
* Spanish speaker with advanced English level.
* Knowledge of clinical trial conduct and applicable clinical research regulatory requirements (e.g., ICH GCP).
* Strong written and verbal communication skills, including good command of the English language.
* Strong problem-solving skills and ability to work through others to deliver results.
* Good understanding of project financials including experience managing contractual obligations.
Location: Madrid, Spain
Type: Full time
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