Вакансія Site manager

European pharmaceutical company is looking for Site manager

Main responsibilities:

• Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• Acts as primary local company contact for assigned sites for specific trials
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Arranges for the appropriate destruction of clinical supplies
• Ensures accuracy, validity and completeness of data collected at trial sites
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management
• Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
• Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site
• Negotiates investigator budgets at site level, if applicable
• Tracks costs at site level and ensure payments are made, if applicable
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
• May participate in the HA and IEC/IRB submission and notification processes as required/appropriate
• May be assigned as a coach and mentor to a less experienced site manager

Requirements:

• Medical education
• 2 years + of clinical trial monitoring experience is preferred
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
• Willingness to travel
• Proficient in speaking and writing English