Site Excellence Partner - FSP

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.

QualificationsPrimary Duties:

Responsible for process, standards and oversight for assigned studies • Responsible for site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance

• Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution

• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks . • Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks • Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control • Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.) • Demonstrate use of data to enhance quality and accelerate study delivery . • Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control • Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standards

• Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs • These may be conducted with the assigned CRA or alone depending on the nature of the issue(s). • Work with Provider CRAs, and other Provider colleagues as appropriate, to drive resolution of oversight issues • Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these • Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery • Identify potential improvements for Client processes • Review of monitoring visit reports Protocol Site Oversight • Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality • Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements Site and Study Management Interface • Support local Investigator relationship management with the Site Relationship Partner. • Serve as point of contact for quality and safety escalations for Provider, CRAs, Site Relationship Partner and Study Team • Support the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables General • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training • Adhere to EP and Client SOPs and processesEEO 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.