Description
We are seeking a Clinical Research Site Manager to oversee remote site monitoring activities, ensuring sites conduct studies and report data according to protocols, regulations, and sponsor requirements.
Responsibilities:
- Conduct site identification, site start-up, and site monitoring activities remotely
- Collaborate with cross-functional teams, including Clinical Operations Lead, Project Management, and Regulatory Start-Up
- Perform site selection visits, prepare regulatory submission packages, and obtain required approvals
- Manage site contracts, budgets, and project timelines
- Serve as primary contact between the business and investigator sites
- Review patient data quality and integrity, and ensure timely transmission of clinical data
- Assist with final data review, query resolution, and patient casebook signature
- Maintain accurate records and track site-specific information
Qualifications:
- Bachelor's degree in a scientific discipline or healthcare
- Basic knowledge of clinical research processes and medical terminology
- Good written and verbal communication skills, including English language proficiency
- Organizational and problem-solving skills, with ability to manage multiple priorities
- Ability to work independently and apply critical thinking
- Familiarity with electronic data capture and basic data processing functions
- Knowledge of ICH and GCP guidelines and applicable regulations
- Proficient in Microsoft Word and Excel
Benefits: None mentioned