A pharmaceutical company in Massachusetts is currently seeking a new Site Monitoring Lead to join their team in a remote capacity. The Site Monitoring Lead will be responsible for developing the study’s monitoring strategy and serving as the primary point of contact for all study-specific questions from internal teams and, when applicable, the CRO monitoring team.
About the Opportunity:
- Hybrid or Remote: Remote
- Shift: Standard business hours
- Schedule: Full-time
- Hours: 40 hours per week
- Setting: Home-based
Responsibilities:
The Site Monitoring Lead will be responsible for:
- Managing SMs for clinical study site/monitoring activities in compliance with ICH-GCP and SOPs
- Partnering with CRO/monitor and LSM to ensure site activation and monitoring readiness
- Supporting LSM on monitoring oversight activities such as monitor and site selection and report reviews
- Assisting LSM with creating and maintaining monitoring plans and study-specific tools
- Facilitating and supporting LSM with SM study-specific training plan and meetings
Qualifications:
- Minimum of 5 years of direct site monitoring experience in a biopharmaceutical, pharmaceutical, or CRO company
- BA/BS required, preferably with a strong emphasis in health or medical science
- Strong knowledge of GCP/ICH requirements and country regulatory requirements
- Proficient IT skills and adaptability to new applications
- Excellent communication skills and aptitude for conflict resolution
- Strong attention to detail and ability to conduct assessment of site performance
- Ability to analyze data/metrics and act appropriately
- Effective time management, organizational, and interpersonal skills
- Ability to work independently with a high sense of accountability
- May require 25-75% travel
Desired Skills:
- 5+ years of experience
- BA/BS with preferred emphasis in health or medical science
- Experience monitoring rare and ultra-rare diseases
- Fluent in English and local languages where applicable
- Ability to establish and maintain culturally sensitive working relationships
