Sr. Site Monitoring Lead

Tandym Group; Massachusetts; Remote; USD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is looking for a Senior Site Monitoring Lead to enhance their monitoring strategy and ensure compliance during clinical studies. This remote position requires significant experience in site monitoring and provides opportunities for professional growth while working in a collaborative environment. Ideal candidates will possess a Bachelor's degree and extensive experience overseeing site monitors in a BioPharma or CRO setting.

Qualifications

• 5+ years of onsite Site Monitoring experience in a BioPharma or CRO setting.
• Experience in managing global teams and site monitors.

Responsibilities

• Manage clinical study site and monitoring activities per ICH-GCP and protocols.
• Support oversight activities like monitor selection and report reviews.
• Facilitate SM-specific training and conduct site visits.

Skills

Site Monitoring

Clinical Monitoring

Project Management

Team Leadership

Regulatory Compliance

Auditing

Education

Bachelor’s Degree

Job description

Direct message the job poster from Tandym Group

A pharma company is actively seeking an experienced professional to join their staff as their new a Senior Site Monitoring Lead. In his role, the Senior Site Monitoring Lead (SML) will be responsible for partnering with the Lead Study Manager (LSM) to develop the monitoring strategy for the study and will be the primary point of contact for study-specific questions from both the internal and where applicable CRO monitoring team.

This is a remote role with approximately 25% travel as needed for onsite monitoring.

Responsibilities:

• Study- level management of SMs for clinical study site/monitoring activities in compliance with ICH-GCP, SOPs, if applicable, Protocol, Clinical Monitoring Plan, and associated documents
• Support the LSM on monitoring oversight activities such as but not limited to monitor selection, report reviews, conduct of Monitoring Oversight Visits, review of monitoring metrics and other monitoring oversight activities as applicable
• Assist the LSM with creating and maintaining monitoring and/or monitoring oversight plans and study specific tools/trackers (e.g., SM FAQ and ISF Reconciliation Tool
• Facilitate the SM study-specific training plan, SM meetings and provide training
• Support LSM in audit/inspection activities and risk and issue management, including development of corrective and preventative actions, relevant to site, SM, and vendor performance
• Conduct visits on behalf of the Site Monitoring and Management team such as monitoring, monitoring oversight and/or training visits, as needed

Qualifications:

• ****5+ years of direct, true, ONSITE Site Monitoring experience in a BioPharma, Pharma, and/or CRO setting***
• Bachelor’s Degree
• Prior experience in oversight or management of site monitors, management of global teams

Desired Skills:

• Experience monitoring rare and ultra-rare disease, genetic disease
• Experience monitoring metabolic disease, pediatric studies, complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Neurology, Transplant, etc.
• Strong knowledge of GCP/ICH requirements, and ability to work within country regulatory requirements and guidelines, as applicable

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing

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