Clinical Trial Manager

hace 3 horas

Madrid, Madrid, España Engineeringuk A tiempo completo
Job Title: Clinical Trial Manager

As a Clinical Trial Manager at Engineeringuk, you will be responsible for leading the local trial team in delivering high-quality data and trial documents/records that meet regulatory requirements.

Key Responsibilities:
  • Coordinate and lead the local trial team to ensure compliance with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
  • Conduct country do-ability and site feasibility assessments in conjunction with CTA, CRA, and PM.
  • Implement local criteria for site selection and ensure consistent conduct of pre-trial assessment visits.
  • Collaborate with the CPL, PM, local management/Country Head, and Protocol Owner to select final site lists.
  • Contribute to the development of trial plans, safety monitoring plans, filing and archiving plans, and investigational product documents at a country level.
  • Lead local project planning activities to meet recruitment targets and deliver high-quality data on time and within study budget.
  • Ensure all Serious Adverse Events (SAEs) and Protocol Violations (PVs) are reported within reporting timelines and documented as appropriate.
  • Maintain and update trial management systems, including CTMS, eTMF/LAF, Trial Master Source, and Sharepoints.
  • Monitor country progress, initiate corrective and preventive actions, and communicate study progress and issues to study management teams.
Requirements:
  • Bachelor's degree in a health or science-related field.
  • Minimum of 2 years of experience as a Lead CRA/LTM/CTM.
  • Experience in submissions and specific therapeutic area experience may be required.
  • Basic understanding of the drug development process, including ICH/GCP and local regulatory requirements.
  • Solid communication and computer skills, with proficiency in speaking and writing the country language and English language.
What We Offer:

At Engineeringuk, we offer a competitive salary, various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a Global Employee Assistance Programme. We are committed to providing an inclusive and accessible environment for all candidates and employees.

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