Clinical Study Manager - Level 1 US
This role will be working on HIV studies with a key asset(s) for ViiV Healthcare. The successful candidate will be a team player with a focus on excellence and operational delivery and stake holder management. This Study Delivery Manager (SDM) role is within the Central Study Team (CST) which is US and UK based. Some flexibility is required to work with the wider global team in different time zones. The ability to work within a complex matrix environment is essential.
Activities may include (but is not limited to) the following:
• In house/outsourced studies, multi-country late phase study management
• Accountable to ensure all relevant studies follow GSK SOPs and GCP.
• With direction, matrix with key study conduct partners.
• Assist with maintaining relationships and monitor performance of CRO's and other vendors.
• With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.
• Manage sites/countries transitioning from study to commercial supplies either via CROs or via LOCs.
• Manage study budgets
• Escalate issues as needed to the Clinical Investigational Lead/medical monitor.
• Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
• Assist in the management of CRO's or other outsourcing partners as appropriate.
• Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
• Senior stakeholder management and collaboration with partners.
The focus of this role is to work together with external stakeholders to deliver clinical operations activities and documentation in preparation for regulatory submissions following the successful early termination of the pivotal registration study.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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