A pharma company in California 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.
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
- Perform other duties, as needed
Qualifications:
- 5+ years of direct Site Monitoring experience in a BioPharma, Pharma, and/or CRO setting
- Bachelor’s Degree
- Strong knowledge of GCP/ICH requirements, and ability to work within country regulatory requirements and guidelines, as applicable
- Knowledge and application of Good Documentation Practices
- Proficient IT skills (Use of MS Office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices
- Solid analytical and problem solving skills
- Great interpersonal skills
- Excellent communication skills (written and verbal)
- Strong attention to detail
- Highly organized
Desired Skills:
- Prior experience in oversight or management of site monitors, management of global teams
- 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
- Knowledge and application of Good Documentation Practices
- Proficient IT skills (Use of MS Office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices
