Senior Study Manager（Resp）

Key Responsibilities Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role Accountable for within-country execution and delivery of assigned studies to timelines, budget and quality expectations as defined in the study protocol as well as in local regulations, IND/ICH GCP guidelines, and GSK written standards. Responsible to provide leadership and drive decisions related to the conduct of a clinical study locally including escalating issues when required. Responsible for matrix leadership and project management of country and site-level activities including oversight of site management & monitoring activities within their LOCs. Serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) / Senior Clinical Research Associates (SCRAs) and other in-country staff aligned to the study. Responsible to lead the identification and sharing of best practices, standardizing across the LOC / region and leads internal / external process improvement teams. Knowledge/ Education / Previous Experience A. Educational Background List any academic or practical education that must be obtained to be qualified to perform this role. 1. Minimum Level of Education Scientific degree or equivalent experience Area of Specialization Any general science degree e.g. life science, medicine, clinical research, pharmacy etc. B. Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role. Minimum Level of Job-Related Experience required Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 5 - 7 years clinical research experience (experience may have been in Study Management, Field Monitoring or similar experience gained at another company); Demonstrates high level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements; Strong knowledge/experience in project management and matrix team interactions. Good English language written and verbal communication skills. Strong negotiation skills Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook). Given the interactions with multi-disciplinary teams and external medical staff （including key external experts）, proven experience in the domain is required. Given the nature of the job and accountabilities for local execution, strong project management and matrix team skills are required to coordinate across all deliverables and lead local study teams to meet time, cost and quality requirements. C. Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. Demonstrates the discipline of risk-based planning, organizing and managing risks / contingency planning to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics. Exhibits strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available); projects, manages and reports budget information (i.e., demonstrates business and financial acumen). Leads teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others. Able to set and manage priorities and performance targets in a local environment Effectively plans, communicates, coordinates and facilitates delivery of team objectives. Solid understanding of local regulations, ICH-GCP guidelines and GSK written standards. Available and willing to travel for project related activities as required (e.g., Investigator Meeting attendance, etc.). Acts as role model in line with GSK core values and behaviors; willingness to mentor/train staff in the study manager and other related positions. Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of GSK systems/software. Applies industry best practices to the execution of clinical studies within country to improve time, budget and resource efficiency. Demonstrates conceptual, analytical and strategic thinking. Effective at problem solving and conflict resolution. Demonstrates good written and verbal communication skills in addition to proven negotiation skills. Flexible with high learning agility. Strong computer skills