Headed by Ivanus Manopo, services comprise:
Specialized, unique skill that combines decades of clinical trials best practices and project management acumen
Comprehensive clinical trials management from study initiation phase to close-out phase
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
Proactively identify potential risks and develop mitigation plan to reduce disruptions and delays
Main point of contact provides single source of information to the sponsor
At SCRI, the clinical project managers support the Sponsor and Principal Investigator by managing intricate clinical trials operations so they can spend more time on what really matters, patient care.
Clinical project managers orchestrate various elements in clinical trials. We are meticulous in planning every phase of clinical trials from developing project plans, supporting protocol development, outlining timelines and milestones, conducting site feasibility, providing patient recruitment strategies, overseeing trial operations, monitoring and control to study close out. We craft a roadmap that not only meets trial objectives but also optimises time and resource allocation. This strategic planning of various clinical trials elements reduces ambiguity, streamlines processes, eases workload for the study team, and sets the stage for efficient trial progression.
The clinical project managers at SCRI understand that coordination is the heartbeat of any clinical trial with the clinical project managers serving as its conductor. Their role in fostering effective communication and collaboration among key stakeholders is invaluable. By acting as the central point of contact, we ensure that investigators, sponsors, study teams, site staff and other key stakeholders are informed and aligned with clinical trial requirements and expectations. This information synchronization is instrumental in preventing delays, ensuring trial is conducted smoothly, and maintaining the quality of data collected.
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 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.