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QUALIFICATIONS/REQUIREMENTS:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required
• A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
• Knowledge of several therapeutic areas is an asset
• Strong proven understanding of GCP, local laws, and regulations
• Strong IT skills and ability to operate and use various systems and databases
• Ability to establish a home office
• Strong team member and self-starter with the ability to work independently
• Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face
• Willingness to travel up to 50% (up to 2-3 days per week) with some overnight stays as necessary
• Proficient in English. Good written and oral communication skills.

• Activities ranging from site feasibility and selection, site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out.
• The implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits.
• Ensuring accuracy and completeness of all trial data including safety data. Managing timely data entry and query resolution in collaboration with site staff.
• Contributing to site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
• Ensuring full documentation of trial related activities in all study files; communicating site and study progress and issues to the Local Trial Managers and central study teams.
• Being the local expert on your assigned protocols and building the necessary therapeutic area expertise.
• Opportunity to be a participant in process improvement and training.