What are the responsibilities and job description for the Remote Site Monitoring Lead position at Sigma Inc?
35656442 Remote 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
