Headed by Gao Hong
Project Management services comprise:
- Planning and organisation, monitoring and control of clinical research projects from study feasibility to close-out
- Protocol preparation and implementation
- Study budget preparation
- Oversight for protocol compliance, adherence to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline and standard operating procedures
- Study progress reporting
- Management and review of times, budget and deliverables
- Primary contact point throughout study
Good communication is vital. We know that they key to a successful project is in identifying study requirements and addressing the needs, concerns and expectations kif the stakeholders in planning and executing the project.
At SCRI, we support the sponsor and Principal Investigator (PI) so they can focus on what really matters, patient care. By managing the set-up, running and closing of a clinical trial, project managers ease the workload of the study team. We enable sponsors and PIs to make sound decisions by overseeing communication with internal and external stakeholders, obtaining regulatory requirements and study updates, and presenting these as digestable reports.
SCRI’s Project Management expertise provides critical project oversight from project planning to study close-out, ensuring effective communication with stakeholders and maintaining project stability.
The team at Project Management realises benchmarks of clinical study excellence via protocol development, feasibility assessment and site evaluations. The department also works closely with stakeholders for the development of study guides like the Monitoring Plan and Study Operations Manual, on top of regularly reviewing budget and timelines to identify potential overruns.
Successful clinical research is a complex combination of multiple strengths. The project manager has a pivotal role in guiding study teams to work together towards common goals, overcome cultural variances and optimise work processes.
The team is committed to supporting clinical research excellence for better treatments for our patients. We seek to have all our project managers certified as Project Manager Professionals (PMP), developing thought leadership and expertise in managing multi-national, multi-centre, investigator-initiated trials. Establishing a central database to consolidate our project knowledge and data over decades will also ensure strength in business continuity.