Local Study Manager

Your Responsibilities:
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. This role is part of the Hub in Upper Providence, PA however the successful candidate can live anywhere within the US.

Details
• 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.

Budget responsibilities:
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

Why You?

Basic qualifications:
• 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

Preferred qualifications:
• 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

Why GSK?:
Why GSK?:

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.

Contact information:
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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