Clinical Study Manager: HIV, Oncology
This role will be working GSK on Phase 3 HIV studies with a key asset for ViiV Healthcare. The successful candidate will be a team player with a focus on excellence and operational delivery. 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 (US/UK only). The ability to work within a complex matrix environment is essential.
Activities may include (but is not limited to) the following:
- In house 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.
- Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.
- Manage sites/countries transitioning from study to commercial supplies.
- 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.
- With oversight manage study start-up, conduct and close-out.
- Assist in the management of CRO's or other outsourcing partners as appropriate.
- Provide input into content and execution of investigator meetings / may present selected topics.
- Provide input into development of CRF.
- Provide input into site selection with coordinated input.
- Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
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