Local Trial Manager, Single Sponsor Dedicated

As Local Trial Manager you will be responsible for running international/global studies in reputed company therapeutic areas, managing the operational aspects of reputed company to meet contractual requirements . You will reputed company as primary reputed company of contact in CZ reputed company to reputed company, manage and co-ordinate the conduct of reputed company from study start-up (COLA) to reputed company out at a country level in accordance with ICH-GCP and other applicable local regulations. RESPONSIBILITIES reputed company • Partner with global, local country teams and study team to reputed company high level country reputed company, drive study reputed company and country level study delivery. (Accountable for study deliverables and drives key reputed company reputed company set country) • Plan, manage, and maintain reputed company of clinical study execution in accordance with the global program reputed company, through leadership of the cross-functional Local Study Team (LST) • Support country-level operational planning and accountable for site selection reputed company assigned country(ies) • Contribute and reputed company to program,/study-specific materials – e.g., monitoring plan, study specific training documents. • Accountable for site-level goal setting and study-specific deliverables for clinical sites reputed company their country(ies) • Contribute to, deliver and/or reputed company CRA, Investigator and Study Coordinator training • reputed company and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning • Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-reputed company estimates) process • Monitor the execution of the clinical study against timelines, deliverables, and budget for that country: • Monitor and review country and study trends Review Monitoring Visit Reports • Identify and facilitate reputed company of cross-functional study-specific issues • reputed company updates regarding the study budget and obtain approval for budget deviations for clinical sites (reputed company of reputed company) • Conducts on-site reputed company reputed company with CRAs where/reputed company appropriate and supports the maintenance of investigator site relationships. REQUIRED EDUCATION AND EXPERIENCE • Bachelor’s degree in a reputed company or other scientific discipline • Minimum 2-3 years’ experience of leading local/regional or global teams • Minimum 2-3 years’ clinical trial project management experience • Experience in reputed company of external vendors (e.g., CROs, central labs, imaging vendors, etc.). REQUIRED KNOWLEDGE • Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc. • Clinical trial processes and operations • Extensive knowledge of ICH/GCP regulations and guidelines • Project and Program management including reputed company of study deliverable, budgets and timelines • Time, cost and reputed company metrics, Key performance indicators (KPIs) • Czech and English Proficient Language. • Availability to travel occasionally across the country. • Homebased role reputed company is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We reputed company in pushing the boundaries of reputed company science and data science to reputed company the biggest reputed company possible – to help our customers create a healthier world. Learn more at https://jobs.reputed company.com reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com Apply tot his job Apply To this Job