Local Clinical Trial Manager - Sponsor Dedicated Apply locations: Madrid, Spain Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: R1441865 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.
Partners 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.
Deliverables: Services rendered will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Complies with relevant training requirements.
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report.
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget.
Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
Contribute to site level recruitment strategy and contingency planning.
Delivers competent vendor management at the country level to support the study.
Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed.
Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines.
Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management.
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections.
Ensure accurate finance reporting and trial delivered within budget.
Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals.
May contribute as a trainer of systems/processes or provide input to functional area in process initiatives.
Full utilization by timely and accurate time reporting.
Experience in management and startup of complex Late Development trials.
Advanced: Autonomy with execution of local trial management services; Depth of knowledge with local trial management services; Process leadership.
Qualifications: Bachelor's Degree Life sciences or related field Req 2 years of local trial management or mutually agreed clinical trial experience.
Advanced: 3 to 5+ years of trial management experience.
Strong experience in Oncology studies.
Spanish speaker with advanced English level.
Knowledge of clinical trials and skill in applying applicable clinical research regulatory requirements.
Strong written and verbal communication skills.
Strong problem-solving skills.
Ability to work through others to deliver results.
Planning, time management, and prioritization skills.
Attention to detail and accuracy in work.
Good software and computer skills, including MS Office applications.
Ability to establish and maintain effective working relationships.
Good understanding of project financials.
Ability to demonstrate all IQVIA competencies.
Based: Madrid IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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