Site Management Lead
Manage Site Activities in Global Clinical and Late Phase Studies
Lead Site Optimization Efforts at a Multinational Pharmaceutical Company
- European bio-pharmaceutical company, with rich development pipeline in immunology, oncology and neurology areas
Ensure delivery of clinical trials (from trial preparation to trial closure and reporting) in terms of
Deliver site monitoring approach for the trial
* Develop Trial Level Monitoring Manual and provide related input into trial plans, processes (e.g. trial risk assessment, Trial ISF/TMF, IMP management,
Supplier selection such as central imaging or laboratory) and documentation (e.g. input into CTP, IQRMP, IC and develop SFQ and other relevant site logs/forms such as source data status report, etc.).
Deliver site monitoring oversight plan for the trial:
* Develop Site monitoring oversight plan and provide related input into trial level supplier oversight plan.
Ensure appropriate training:
* Provide input into trial training plan and develop and deliver trial-specific training for Clinical Research Associates (CRAs).
Support streamlined data collection:
* Provide input into eCRF
* Support development of checklists/templates (as appropriate) and support IRT set-up (input into IRT requirements/set-up and conduct UAT)
* Participate as appropriate in trial team meetings, International/regional investigator meetings and Drug supply meetings
Oversee site monitoring activities in the trial
* Issue management / oversight on trial level: review and assess site issues, escalate to CTL as appropriate, prepare for trial oversight/MQR meetings and follow up on further actions with countries when applicable
* Pre-identify important protocol deviations from site issues/deviations for CTL(and TSTAT)or CTM to take final decision.
* Proactive risk mitigation: perform regular risk indicator review as applicable and determine and follow up on required actions
* Maintain site monitoring approach for the trial and update Trial Level Monitoring Manual, site monitoring oversight plan and other core trial documents such as ISF templates etc. as required
* Conduct process and site quality performance monitoring and checkpoint calls or visits with the CRAs in a trial according to the site monitoring oversight plan, implement follow-up actions and escalation as required
3) Site close-out
Coordinate DBL planning with Trial Team and countries.
Support compilation and review of the quality section for the clinical trial report for site monitoring activities.
4) All phases
Facilitate communication and training related to site monitoring in the trial:
* Communication with CTMs, CRAs, perform re-training etc.
* Participate, prepare input and (co-)lead trial oversight meetings
Deciding, problem solving, independence
Communication, cultural sensitivity, clear and transparent, internal and external focus, collaboration and team work
Digital solutions for trial management
Driven to learn and grow
Solid knowledge in and experience with site monitoring processes and expertise with relevant tools and systems (e.g. Electronic Data Capture (EDC), Site Management System (SMS)).
Capable of performing site monitoring activities (CRA responsibility) at any stage of a clinical trial if required
Excel, Word, Outlook, Powerpoint, Internet
Promote continuous improvement and learning culture
1. Take initiatives for continuous improvement of quality, efficiency and productivity in COJ to achieve Our Vision and priorities.
2. contribution to build a learning culture within COJ for shared learning
- Contribute to the effective development of drugs within the speciality care area
- Work in global clinical trials as part of Japan and East Asian Hub
- Promotion opportunities in Clinical Trial Management area