Local Clinical Trial Manager

Highly Competitive
  1. Permanent
  2. Clinical Trial Assistant (CTA)
  3. Germany
Germany
Posting date: 12 Oct 2020
33494

ProClinical are currently recruiting for a Local Clinical Trial Manager job in Germany. This a great opportunity to further establish your Clinical career.

Job Responsibilities

  • Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations.
  • Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed.
  • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates.
  • Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
  • With focus on quality, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM.
  • Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.


Skills and Requirements

  • BA/BS degree.
  • Degree in a health or science related field.
  • 2 years of local trial management experience.
  • 3 to 5+ years of trial management experience.
  • Specific therapeutic area experience may be required depending on the position.
  • Strong working knowledge of ICH GCP, company standard operating procedures, local laws and regulations
  • Good written and oral communication skills as appropriate.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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