Local Clinical Trial Manager

hace 1 día

Madrid, España IQVIA LLC A tiempo completo
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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