Local Trial Manager

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines aligning with company Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies

• Ensures, as the need arises, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in  clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
• Ensures all country and site level trial crucial documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs
• Oversees, handles and coordinates supervising activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans
• Reviews supervising visit reports (as the need arises and following SOPs) and pro-actively advices the monitor(s) on study related matters
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study

CRAs

• Proactively identifies risks and facilitates resolution of sophisticated study problems and issues
• Organises regular Local Study Team meetings on an agenda driven basis

• Ability to lead several local studies in parallel
• Good decision making and delegation skills
• Basic change leadership skills
• Basic coaching skills
• Basic ability in handling crisis situations