Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This position is a fully client-embedded role, dedicated to a leading bio-pharma company. Job summary: To lead local study teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with international guidelines such as ICH-GCP as well as relevant local regulations. In addition may perform site monitoring as needed to support the flexible capacity model. The position is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. Responsibilities include but are not limited to: • Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies • Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. • Ensures, as required, 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 essential 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. • Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. • Reviews monitoring visit reports (as required 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 complex study problems and issues. • Organises regular Local Study Team meetings on an agenda driven basis. • Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders. • Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. • Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary. • Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. • Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.