Clinical Site Manager

Ascent Services Group

(Princeton, New Jersey)
Full Time
Job Posting Details
About Ascent Services Group
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.
Summary
* 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.
Responsibilities
* 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.
Ideal Candidate
* 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.)

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