Description
Local Trial Management services provides 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), Clinical Research Associate (CRA) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Essential Functions
- 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 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.
- 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 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.
- Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training, when needed.
- 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.
- 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 and developing therapeutic knowledge enough for role and responsibilities.
- With focus on quality and compliance, will work closely with CRA to ensure CAPA is implemented for audits/inspections or any quality related visits.
- Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines.
- Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, if as applicable.
Education and Experience Requirements:
- BA/BS degree.
- Degree in a health or science related field.
- 2 years of local trial management or mutually agreed clinical trial 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.