Global Site Monitoring Lead

Start: 09/24/2023

End: 09/19/2025

Interview Notes: Highly prefer east coast candidate. Please make sure you enter your candidates location

Required Skills:

PROJECT MANAGEMENT

CAPA

RISK ASSESSMENT

CLINICAL TRIAL MONITORING

DERMATOLOGICAL

Additional Skills:

CLINICAL SITE MONITORING

ONCOLOGY

CLINICAL MONITORING

Skills:

Oncology experience

metabolic experience

Dermatology experience

CNS experience

2 spots

Description:

Reason: Special Project

Department: CLINICAL SITE MONIT

Job Category: Clinical and Scientific

Job Title: Global Site Monitoring Lead

Duties: Trial Preparation:

-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)

- 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.

- Work with CRAs to report compliance issues with their sites, as appropriate, and support the development and execution of corrective action plans.

- Review internal audit report observations and support CRAs to develop a plan for addressing actions.

- Promote customer-centric behaviors with all external site facing resources to enhance BI's reputation.

Trial Close-out:

- Coordinate timely cleaning and delivery of clinical trial data within OPU.

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.

Job Type: Contract

Pay: Up to $105.00 per hour

Benefits:

• 401(k)
• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Ridgefield, CT: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Linux: 1 year (Preferred)
• Cybersecurity: 1 year (Preferred)
• Information security: 1 year (Preferred)

Work Location: In person

Salary : $105