Uk739 Senior Local Trial Manager

Detalles de la oferta

.The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The LTM III is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.The LTM III role actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM). Compared to LTM I and LTM II roles, an LTM III is often assigned to more complex protocols and can work across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs. The Local Trial Manager III may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for a single country as described in GCO procedural documents.Principal Responsibilities:Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL.Implement any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommend suitable sites for selection to participate in trial.Collaborate with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team members to select the final site list.Contribute input to the study management documents at a country level or initiate development of these documents for a single country trial, as per SOPs.Lead and coordinate local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.Lead local project planning activities to meet recruitment targets and deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.Maintain and update trial management systems. Use study tools and management reports available to analyze trial progress.Monitor country progress and initiate corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams.Submit requests for vendor services and support vendor selection


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Field Project Manager -

Job Title: Field Project ManagerLocation: Remote (CST Time zone)Salary Range: up to 2000 USDWork Schedule: Monday - Friday, 7:00 AM to 4:00 PM (CST)NOTE: IND...


Sagan - Madrid

Publicado 14 days ago

Project Manager - Real World Evidence- Late Phase Research

Project Manager - Late Phase Research - Europe - Home or Office BasedICON plc is a world-leading healthcare intelligence and clinical research organization. ...


Icon - Madrid

Publicado 14 days ago

It Senior Project Manager (F/M/D)

Do you want to help create the future of healthcare? Siemens Healthineers is a place for people who dedicate their energy and passion to this greater cause. ...


Siemens Mobility - Madrid

Publicado 14 days ago

Technical Program Manager (Sustainability)

-We're Celonis, the global leader in execution management and process mining technology, and one of the 50 most valuable private companies in the world. We b...


Celonis Se - Madrid

Publicado 14 days ago

Built at: 2024-12-27T19:46:52.569Z