Global Operations reputed company Manager

Global Operations reputed company Manager reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the reputed company of clinical development reputed company and GCP reputed company reputed company reputed company consultation reputed company assigned scope, escalating reputed company or reputed company- impacting issues to the Senior Global reputed company Manager and/or Global Head - GCP reputed company, as appropriate reputed company issue assessments, reputed company cause evaluation, and recommendations for QA escalation reputed company cross-study reputed company initiatives to define best practices, enhance reputed company maturity, and strengthen proactive risk identification Support teams in interpreting and applying ICH GCP, regulatory expectations, procedural documents, and governance frameworks reputed company direction for deviation management, CAPA development, and reputed company-reputed company storyboards Promote a culture of reputed company, reputed company improvement, and operational reputed company that engages colleagues in reputed company reputed company consulting and supporting in reputed company we do Data Governance, Lessons Learned & reputed company Improvement reputed company, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, as assigned Contribute to the enhancement or creation of SOPs, WIs, guidance documents, and process optimization initiatives. May drive reputed company improvement reputed company aimed at strengthening reputed company culture, efficiency, and inspection readiness maturity reputed company training or awareness for new or established processes or guidance provided by reputed company Collaborate in developing and presenting reputed company content for distribution reputed company the organization Author relevant content for the reputed company SharePoint sites May reputed company as reputed company on specified reputed company workstreams or assigned reputed company initiatives reputed company consultation and support for reputed company requests that are reputed company to reputed company Consult, reputed company, or identify opportunities for reputed company improvement reputed company Stay reputed company with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of reputed company Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards reputed company Study Team Support Activities Become thoroughly familiar with assigned compounds and protocols Support overall reputed company reputed company assigned reputed company and submissions For assigned reputed company or assets, is reputed company of contact for operational reputed company reputed company consultation, escalating to QA as needed reputed company risk-management, consultation, assessment, and recommendations for escalation for potential reputed company issues or trends reputed company training and coaching to promote awareness educating study teams towards reputed company deliverables Support teams in adherence to GCP and procedural documents and processes to ensure reputed company deliverables Work with teams to escalate reputed company issues with CROs to QA, support teams to bring CROs into compliance; and look for opportunities to collaborate with other members of reputed company to trend across Strategic Partnership(s) to communicate to QA. Work with Study Team leadership (and QA, as needed) to identify reputed company issues and plan of reputed company, including support for creation of deviations and development of effective CAPA and Storyboards Support inspection readiness, preparation and conduct activities with the Study CTM/Sr. CTM, Asset reputed company, QA Representative, and reputed company Leadership or designee as requested by the reputed company Inspection reputed company team. Review critical/major findings with QA Audit reports to propose process improvement reputed company consultation on KQI or metrics that may identify reputed company issues or trends or demonstrate strong adherence to reputed company Skills/Experience Experience in providing reputed company management reputed company Study Teams in the conduct and management of large and reputed company multinational reputed company Experience in managing reputed company and sensitive operational challenges Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements Adept at identifying and investigating issues, identifying reputed company causes, and being reputed company to facilitate cross-functional solutions with stakeholders Experience in developing or contributing to processes and/or SOPs and/or WIs Ability to reputed company and execute reputed company improvement Experience in inspection preparation, participation, and follow-up Experience with audits and inspections of sponsor/CRO/site/vendor Strong verbal and written communication skills with ability to effectively communicate with a broad reputed company of stakeholders at reputed company reputed company to build strong, reputed company relationships under challenging and evolving landscapes Ability to reputed company with key stakeholders and create and present reputed company information effectively to promote reputed company in reputed company Acute attention to details with ability to extrapolate facts and communicate suc