FSP Lead Risk Based Monitor

About ExecuPharm:

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Job Responsibilities: Reviews and provides feedback on the clinical monitoring plans, and other key documents impacting the monitoring function at clinical research sites. Provides oversight for site management activities performed by CRO at clinical research sites some of which may be conducting multiple protocols. Represents the client when interacting with Vendors, CRO and clinical research sites. Represents client in overseeing CRO performance of: Establishment of risk based monitoring plan/centralized monitoring plan Conduct of monitoring visits (i.e., SIV, IMV, COV), onsite or remote (virtual) follow-up and resolution of issues identified during monitoring visits. Provides guidance to the CRO related to regulatory compliance, patient safety, data quality and timely resolutions of issues. Reviews monitoring reports and other types of reports provided by the CRO, and tracks trends in performance that may potentially impact patient safety and data integrity. Tracks site performance and, as appropriate, escalates issues. Meets with CRO team as needed to track the conduct of centralized data review and the integration of centralized monitoring with the on-site/remote monitoring. Identifies and or recommends opportunities for process improvements. Stays abreast of relevant ICH, GCPs and other regulatory requirements to ensure compliance. QualificationsMinimum Qualifications and Skills: Bachelor's degree or higher, medical and/or science preferred. Demonstrated knowledge of and experience with remote, virtual, and onsite clinical monitoring, either within a sponsor organization or with a Vendor (note, client currently working with PPD). Experience with industry best practices for risk-based clinical monitoring. Computer skills to include Microsoft office and CTMS experience. Strong communication skills. Ability to meet time constraints and work well under pressure. Ability to bring a high-level of expertise, confidence and maturity to a rollup the sleeves, team-based environment that values collaboration, transparency, and pride in the quality of the work. EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.