What are the responsibilities and job description for the Remote Global Site Monitoring Lead position at Sigma Inc?
35605648 Remote Global Site Monitoring Lead, Ridgefield, CT, 12 Months
Sigma Systems is seeking a Site Monitoring Lead to work remotely.
Responsibilities:
Sigma Systems is seeking a Site Monitoring Lead to work remotely.
Responsibilities:
- Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US-conducted trials (~5-8) across therapeutic Area(s) phase depending on complexity, size, and stage of study.
- Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
- Implement the monitoring plan as part of the trial team. Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s) (e.g., BI CTMS).
- Deliver a risk-based site monitoring approach and local training for the trial.
- Develop and provide appropriate training of local trial teams (e.g., clinical trial managers (CT managers) and clinical research associates (CRA)).
- Assist with in-house site monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
- Behave as a local expert and consultant on site management and monitoring topics.
- Participate in and contribute to global/regional and local trial team meetings and international/regional/local investigator meetings.
- Timely responses to Site management and monitoring questions from external and internal stakeholders (including the Regulatory Authority/Ethics Committee).
- Trial Conduct:
- Monitor progress and oversee site management and monitoring activities conducted by CRO partners during clinical trial conduct, including adherence to ICH-GCP and regulatory requirements, compliance with SOPs, trial protocol, trial quality management, and site monitoring plans.
- Including but not limited to:
- Issue management and oversight at the country level.
- Continuous review, risk identification, evaluation/analysis, and communication on a country level as applicable.
- Maintain a risk-based site monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
- Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan and implement follow-up actions and escalation as required.
- In conjunction with SML-r, contribute to the preparation and implementation of trial-level documents, including training material updates and retraining as needed.
- In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU:
- Communication and training of CT managers and CRAs. Performing re-training as necessary.
- Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level), and contribute to the timely responses to questions from external and internal stakeholders.
- Bachelor's Degree (Health Sciences, Health Care, Nursing, or Others) required with a minimum of 5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
- Oncology experience
- metabolic experience
- Dermatology experience
- CNS experience
