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Site Monitoring Lead

4 months ago

Ridgefield, United States TruMinds Technologies Full time

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 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 Manager) 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 local expert and consultant on site management and monitoring topics.
- Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
- Timely responses to Site Management and monitoring questions from external and internal stakeholders (including 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 / oversight on country level.
- Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
- Maintain 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, implement follow-up actions and escalation, as required.
- In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/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.

**Skills**:Oncology experience
metabolic experience
Dermatology experince
CNS experiecne

Keywords:
Education: 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.
Skills and Experience:
**Required Skills**:
PROJECT MANAGEMENT
CAPA
RISK ASSESSMENT
CLINICAL TRIAL MONITORING
DERMATOLOGICAL
Additional Skills:
CLINICAL SITE MONITORING
ONCOLOGY
CLINICAL MONITORING
Languages:
English
Read
Write
Speak
Minimum Degree Required: Bachelor's Degree
Patents: No
Publications: No
Veteran Status: No
of Positions: 1

**Location**:
Ridgefield, CT
900 RIDGEBURY RD BLDG AOB,

Pay: $85.17 - $86.99 per hour

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance

Schedule:

- Night shift

Ability to Relocate:

- Ridgefield, CT 06877: Relocate before starting work (required)

Work Location: In person