Posted: Friday, February 16, 2018 10:19 PM
Our client, a RTP-based pharmaceutical company with a rich and expanding pipeline, is actively recruiting for a highly skilled and knowledgeable candidate to assume leadership role on its Clinical Research team. Company is considering Associate Director and Senior Manager level candidates. Company will pay excellent wage to attract and retain the right candidate. Key things to note: * Company has multiple products in development and this AD/SM will focus on Phase II and III global trials. * This is a strategic and tactical role, helping to ensure that all Clinical Projects are being run in a smart, compliant and efficient matter. It is not a supervisory role. * Position will involve oversight of CROs, and related experience is a must. * This AD/PM will be responsible for extensive budget and forecasting work. Right candidate will complement impressive Clinical PM credentials with demonstrated ability to lead financial elements of Clinical Operations. * Company is building. Right candidate will thrive in an emerging business setting in which policies and practices are being developed, revised and enhanced * Travel is estimated at 10% This Associate Director/Senior Clinical Project Manager will serve as a member of Project Management leadership and will be responsible for helping to ensure that timelines, budgets and deliverables are met. This AD/SM will be in constant contact with Clinical Teams and ensure that they have the information and support needed to ensure success. Specific responsibilities will include: * Coordination and project management of clinical trials, including organization of the trials, tracking and management of budgets and timelines * Work with Regulatory or other team members on responses to questions occurring during the regulatory approval process (by Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs, etc.) * Contribute to or creating clinical operations SOPs (Standard Operating Procedures) * Ensure that Clinical Trial Teams follow SOPs and regulatory guidelines such as ICH GCP * Serve as the key contact for contracted CROs, and ensure accurate and timely information flow within the cross-functional team * Serve as primary reviewer for project level study plans and amendments (eg, project plan, monitoring plan, risk plan) and provide/coordinate input on all other functional group plans (eg, data management plan, medical monitoring plan, safety management plan) * Review regulatory submission packages (eg, CTAs) from an operational perspective and provide feedback * Oversee finance requirements for clinical trials such as accruals and forecasting * Review vendor payments/invoices to ensure they are in-line with agreed upon contracts * Review site essential documents and IP release packets * Respond to investigative site questions and CRO regarding protocol issues and implementation Right candidate will offer a related degree and 7+ years of clinical project management experience within a pharmaceutical company and/or Contract Research Organization. Phase II/III experience in a global setting will be essential. Infectious disease and/or antivirals experience is preferred. Other priorities include: * Broad and deep knowledge of international regulatory guidelines and Best Practices for the conduct of multinational trials * Extensive experience in Clinical Operations Management, including budget and forecast oversight, SOP writing, etc. * Extensive experience overseeing the work done by CROs * Exceptional project leadership skills * Exceptional communication skills * Longevity and impact in previous roles Finally and critically, we seek a candidate with a track record of success in emerging pharma settings in which process is being developed and trailblazing is expected. This is an excellent opportunity for a highly qualified professional to have significant impact. Growth potential is enormous.
• Location: Raleigh / Durham
• Post ID: 59835467 raleigh