Clinical Lead II - Rare Disease / Oncology

Premier ResearchBulgariaonsiteSalary not postedView the original posting at Premier Research ↗

Premier Research is looking for a Clinical Lead II - Rare Disease / Oncology to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: Serves as initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP). Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables. Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan. Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines. Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings. Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting. What We Are Searching For: Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience At least 2 years of experience as a Clinical Lead (ideally global) gained in a CRO setting and must have prior onsite monitoring experience, ideally to include Risk-Based Monitoring. Must have prior experience in both Rare Diseases and Oncology. This will ideally have been gained as a Clinical Lead managing trials vs solely in a CRA capacity. Biliary liver disease therapeutic experience, Oncology experience in CAR-T and / or Cell Gene Therapy in addition to experience working on pediatric trials will be the optimum. Working knowledge of clinical financials including understanding of budgets, pass- through and resource management

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Premier Research you can reach out to

22 of 47 public LinkedIn profiles found in searches for Premier Research list Premier Research in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More CRA jobs