Project Manager, Evidence Solutions at Abbvie

JOB SUMMARY Project Manager is responsible for executing clinical studies (including but not limited to Phase IV clinical trials, epidemiology studies, Patient Report Outcome study, product registry, disease registry, data extraction and management of Investigator initiated studies) in compliance with relevant quality standards. Project Manager also takes the responsibility of clinical trial disclosure process, study drug management, sourcing process, budget management, and payment process, as well as be responsible for auditing and archiving per requirements. CORE RESPONSIBILITIES: Phase IV clinical trial Responsible for execution and management for Phase IV clinical trials which include Post-approval commitment study (PAC), Post Marketing Observational study (PMOS) and interventional studies using AbbVie product as an investigational drug. - Site selection and management: screening and selection of sites and investigators, and work within teams to provide scientific and technical support and leadership for feasibility of conducting the trial. - Develop site patient recruitment strategies. - Database and data management: establish database and Electronic Data Capture (EDC). - Budget planning and management: responsible for budget planning, phasing, daily management, and relevant financial communication. - Contract management: responsible for contract preparation, negotiation, finalization, and signature with hospitals, institutions, and vendors. - Insurance and subjects AE compensation in clinical trial as needed. - Investigational drug packaging and distribution as needed. - Responsible for regular update to cross-functional team and stakeholders on study status. - Ensure our clinical trial management system is up to date. - Support communication with biostatistics and cycle analysis/research report. Investigator initiated studies and other programs - Responsible for sponsorship qualification, contract negotiation, signature, payment, and investigational drug packaging and shipment scheduled for Investigator Initiated Studies. - Provide proper advice/support to sponsor on EC process and regulatory submission as needed. - Responsible for other data generation projects from qualification assessment to contract process and payment schedule. - Work with stakeholders to facilitate research grant, third party studies, In vivo/in vitro assessment, contract process and payment schedule if needed. Vendor management and sourcing - Responsible for vendor selection, project scope development, and oversight of vendors in compliance with AbbVie processes, procedures, and applicable regulations. - Responsible for quality control of the service provided by vendor according to AbbVie standards. People and performance management - Lead contract CRAs on site identification, qualification, initiation, monitor and study close-out visits. - Lead contract CRAs on conducting quality patient recruitment per plan, and other operational tasks in a highly efficient way. Documentation, system, and compliance - Archive all the essential documents across the project life cycle in required systems and format. Ensure the access control, version control, and information security. - Ensure all the AbbVie information assets, including electronic database on service provider side, are compliant and secured. Archive the database within AbbVie when the project is completed. Quality assurance, audit, and inspection - Ensure that all activities and interactions are conducted with due regard to all applicable industrial, global, and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice. - Ensure adherence to regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), monitoring plans, and quality standards in conducting clinical research. - Monitor regulatory reforms and industry trends within country. Conduct and/or implement impact analysis of all significant changes to conform with updated regulatory/industrial regulations. - Work with relevant functions to ensure the project quality control, and no critical findings from internal audit. - Always ensure audit-readiness and inspection-readiness. Plan and conduct self-inspection working plan if needed. - Serve as a country contact for regulatory questions related to monitoring processes and procedures.