Local Trial Manager
An exciting opportunity has arisen for a Local Trial Manager to join a well-established pharmaceutical company. You will ensure that local trial team is delivering quality data and trial documents. You will be expected to lead these services ensuring compliance and quality.
- Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of pre trial assessment visits and appropriate follow up of pretrial visit report and country feasibility report.
- Collaborates with central study team for final selection of sites to participate in trial.
- 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. May schedule and conduct a local/country investigator meeting.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
- Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed (i.e. implementation of study amendment and changes in study related processes).
- Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- 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.
- Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
Skills and Requirements
- BA/BS 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, assigned protocols and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.