Local Clinical Trial Manager
ProClinical are currently recruiting for a Local Clinical Trial Manager job in Germany. This a great opportunity to further establish your Clinical career.
- 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.