Local Study Manager
The Local Study Manager (LSM) is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial in the U.S. The LSM leads and manages the operational implementation of within-country feasibility, planning and delivery of US R & D Pharma Phase I-IV clinical studies within and across therapeutic areas. The LSM is accountable for within-country execution and delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Pharma, and local SOPs and POLs. The LSM serves as the operational point-of-contact between the Central Study Team and in-country operational staff, including Clinical Research Associates (CRA) and other in-country staff aligned to the study.
• Primarily allocated to Oncology studies
• Provides operational insight during protocol design.
• Accountable for operationalizing assigned studies within country and overall project management of study activities
o Ensures development and maintenance of country study plan and forecast, including detailed budgets, resource estimates, milestones, timelines, quality, and risk planning
o Manages in-country study communications & issue escalation; communicates progress & escalates issues to the Operations and Science Leader (OSL) and other functions (i.e., Head of Study Management (HSM)
o Develops/manages the development of local aspects of key study documents, plans & manuals (e.g., monitoring plan, study reference manual, etc.); develops local recruitment and other site support materials
o Coordinates as necessary key local requirements including local informed consent form, institutional review committee approvals, clinical study agreement (CSA), third party agreements & payments
o Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for CRO & vendor management including oversight, payments, communications & issue management
• Accountable for local activities required in study design and set up
o Conducts country/site feasibility
o Serves as single point of contact (POC) for country/site questions
o Provides input into study design, logistics & CRF development; assess appropriateness of study for local environment
o Coordinates activities of all other in-country operational staff to deliver study objectives & ensures appropriate training of in-country staff and investigator sites
o Leads selection of sites within country; accountable for site performance
o Reviews and manages IRB documents and submissions; including changed to model consent
o Arranges accurate translations of key study documentation
o Ensures necessary supplies are available at sites and manages local supply inventory
Accountable for high quality execution/delivery of studies within country as defined by protocol & per agreed to timelines/budget
o Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites' progress and issues; reviews in-country protocol deviations; ensures appropriate issue escalation & follow-through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed
o Provides direction and establishes study-related objectives for local operational staff (CRAs, other local support staff)
o Ensures implementation of in-country study-specific quality assessments (Business Management Monitoring); POC for regulatory/compliance audits of assigned study(ies); provides input into site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports
o Ensures development of country-level study risk assessment and mitigation plan
o Specifies and reviews in-country study monitoring tools, monitors key risk and performance indicators and other reports
o Monitors country and site enrollment and takes corrective actions
o Coordinates & delivers operational aspects of local study meetings including investigator meetings, monitor meetings, local training, etc.
o Benchmark and build clinical study budgets, ensuring financial governance
o Develop and report clinical study budget forecasts
o Estimate, track and deliver against the local clinical budget for assigned studies within scope of LSM responsibilities
o Accountable for budgets up to $10 million in external project spend
o Advise on contract development with CRO/Vendors
o Participate as required in budget/contract negotiations with study vendors or clinical investigator sites
o Ensure timely payments per contract and approve payments up to $25K related to clinical study activities within the US
• BS/BA degree in a health-related science
• A minimum of 5 years clinical/research experience (can be in Study Management, Field Monitoring or similar experience)
• Demonstrated high level of understanding of clinical research and clinical trial management, and the associated regulatory, process and quality requirements
• Demonstrated strong knowledge and experience in project management and matrix team interactions
• Demonstrated operational expertise in risk management and contingency planning, understanding of local regulations, GCP/ICH-guidelines and GSK SOPs/POLs/guidelines
• Availability and willingness to travel for project related activities as required (e.g., Investigator Meeting attendance, etc.)
• Strong Oncology background
• Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Demonstrated excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements
• Experience with discipline of risk-based planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics
• 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)
• Ability to lead and work within 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, resources, performance targets in a local environment
• Effectively plans, communicates, coordinates and facilitates delivery of team objectives
• Ability to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of GSK Pharma systems/software
• Experience applying industry best practices to the execution of clinical studies within country to improve time, budget and resource efficiency
• Demonstrated conceptual, analytical and strategic thinking
• Effective problem solving and conflict resolution skills
• Demonstrated good written and verbal communication skills, and proven negotiation skills
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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