Clinical Trial Monitoring/site Monitoring Lead - Ridgefield, United States - Adientone

Adientone
Adientone
Verified Company
Ridgefield, United States

2 weeks ago

Mark Lane

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Mark Lane

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Description

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 onsite visits to assess CRA performance, including comonitoring/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 Riskbased 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 inhouse 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 Riskbased 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 followup actions and escalation, as required.
  • In conjunction with SMLr, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
  • In conjunction with SMLr, 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 SMLr) 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


Job Type:
Contract


Pay:
$3, $3,500.00 per week


Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work Location:
In person
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