Clinical Site Manager

Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry.

• Accountable for providing site/CRO oversight on the unblinded site management activities (primarily study drug-related) for a number of Phase 2-4 clinical studies which are fully outsourced to CROs.
• This includes, but is not limited to, study drug temperature control/management at the site and during shipping, site drug reconciliation, study drug expiration management, etc.

• Site training and set-up for drug receipt, CRO oversight plan development and implementation of unblinded activities.
• Reviewing unblinded monitoring reports in compliance with processes and regulatory requirements, including co-monitoring with the CRO as needed, managing unblinded issues, including trend analysis across sites and studies.
• Ensuring the unblinded activities on the assigned trials are inspection-ready at all times.
• Works closely with the US trial teams and CRO to ensure all blinded study drug-related items are managed in accordance with SOPs, processes, and procedures.

• Bachelor's degree or equivalent qualification in life science/healthcare
• Must have at least 3 years of on-site monitoring experience (previous CRA role preferred, 5+ years or Lead CRA/Site Manager experience)
• Previous experience monitoring drug product at clinical sites is required
• Strong organizational, prioritization skills
• Strong interpersonal skills
• Strong leadership and communication skills
• Strong team player
• Ability to work under pressure
• Ability to work in a matrix environment
• Ability to travel for co-monitoring visits (US only) - 10-20% travel
• Provides innovative ideas and solutions for effective drug management (tracking, temperature deviations, etc.)