职位描述

职位描述： Job facts - Provide essential operational co-ordination and support to Country Study Managers (CSMs) and Local Study Teams (LSTs): - Project Management: - Identify, develop and maintain operational templates and tools based on the needs of assigned studies. - Proactive contribution to study start-up and patient recruitment strategies and activities to support efficient trial management. - Proactive study communication via development and distribution of affiliate newsletters for investigators and LSTs, as required. - Manage shared study area/s according to Roche standards. - Responsible for oversight of study-related supplies. - Support CSM(s) by ensuring that Monitors have site recruitment plans, that site activations occur according to planned timelines and there is timely closure of non-productive sites. - Compliance: - Ensure appropriate tracking systems and tools are in place to ensure compliance to regulations, internal policies, ICH-GCP and GPP (when applicable). - Responsible for the co-ordination and oversight of local affiliate study level audit / inspection audit action plan activities. - Responsible for clinical trial data disclosure completion per local regulatory requirements. - Relationship Management: - Build and maintain effective working relationships with LST members and study site staff. - Perform/coordinate protocol and site level feasibility activities including evaluation of patient population and final site selection. - Support CSM and SSU related activities as required. - Coordinate/execute local investigator and LST meetings where required. - Liaise with Roche science/medical teams (either local or global, as required) for timely resolution of questions- Acts as a single point of contact for study CRO monitors for monitoring related activities. - Provide feedback to local vendor management on performance of CTM CRO staff as required. - Develop Operational Elements at a Country Level: - Coordination: - Provide input into project management and monitoring plans. - Coordinate study or country communication plan, budget and payment plan based on country financial plan. - In collaboration with CSM, maintain track and update country level resource plans. - Create and/or maintain study or country recruitment plan for assigned studies. - Ensure collection of site level documents to support country ethics approval and health authority processes. - Ensure all country ethics / HA approvals are in place for assigned studies. - Localization: - Ensure accurate translation of all documents, as applicable. - Provide required local customs documentation to meet country requirements for importation / exportation, as applicable. - Provide proactive project co-ordination and study oversight actively involving respective internal and external LST members: - Ensure trial management tracking tools are updated in a timely manner to ensure systems are accurate. - Provide regular status and activity reports to CSMs and relevant LST members. - Ensure that monitoring reports are being submitted by Clinical Research Organization (CRO) and escalate to CSM as needed; Review monitoring reports in conjunction with CSM as required. - Manage country-level Trial Master File (TMF) and review for quality. - Manage the secure document exchange and SUSAR reporting process during the conduct of the study. - Assist with the review and tracking of safety procedures to ensure they are being followed, escalated and resolved as necessary. - Ensure database lock activities are within timelines in collaboration with CSM. - Provide feedback of local suppliers/vendors to vendor manager. - Ensure local drug label review and approval is conducted to country requirements. - Identify opportunities for efficiencies and share best practices with other LSTs.Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies- Where a job title is not considered the final definition of who you are, but the starting point. - Qualifications: - University Degree or Equivalent preferably in a medical/science-related field. - Prior work experience demonstrating knowledge and understanding of clinical trials. - Previous experience managing projects is desirable. - Skills, Experience and Competencies: - Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork. - Able to prioritize and manage multiple tasks with high flexibility. - Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality. - Self-motivated and displays initiative/resourcefulness. - Ability to work independently with limited supervision. - Strong attention to detail. - Demonstrated computer literacy, usage of MS Office software, web-based systems and databases. - Ability to communicate clearly and accurately in both written and spoken English.Who we are - At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. - Roche is an equal opportunity employer. 职能类别： 临床研究员 其他

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