Services Overview:
Local Trial Management services provide 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), Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Deliverables:
- Services rendered will adhere to applicable SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
- Complies with relevant training requirements.
- 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. Collaborates with central study team and local stakeholders as applicable 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. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- 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.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary, initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team.
- 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.
- 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 (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements. When issues are identified or trends across a project are noted from MVR review, will escalate deviation issues to CTM/GTL and J&J FM in timely manner.
- 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 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.
- 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.
- May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable.
- Full utilization by timely and accurate time reporting.
- Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable.
- If applicable, region-specific deliverables will be specified.
- Advanced: Autonomy with execution of local trial management services.
- Depth of knowledge with local trial management services.
- Process leadership.
Metrics/KPIs: Quality and Operational metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces – Primary/Other:
Primary interfaces: Provider Functional Manager, company of Contact, Clinical Trial Assistant (CTA), Site Manager (SM), Clinical Trial Manager (CTM)/Global Trial Manager (GTM) and Global Trial Leader (GTL).
Other interfaces: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Contracts and Grants Managers, Local Drug Safety Officer (where required), R&D Country Head, Feasibility Leads, Data Managers and Central Study Team, Investigators, Trial personnel including study coordinators, pharmacists, etc., external vendor representatives and Ethics Committee and others, as required.
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.
- Advanced: 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. Willingness to travel with occasional overnight stay away from home according to business needs.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
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