Eagle is a specialty pharmaceutical company working to advance safe and efficient injectable treatments for patients across oncology, critical care, and orphan diseases.As a group of inventors, visionaries, and life science leaders, we are bound by the belief that patients deserve the best possible experiences in healthcare. Thats why our focus on engineering new formulations is designed to make life-saving medicines easier to use. We discover and develop new formulations to make medicines more convenient and faster to use. We look to unlock the potential in proven medicines to benefit more patients and healthcare providers.Our goal is to provide safe and accessible products through the application of innovative formulation technology to FDA-approved medicines, as well as through the discovery and development of novel therapeutic agents.
Eagle is seeking a qualified Senior Clinical Study Manager for the temporary position with the possibility of becoming a direct-hire. Primary responsibility includes assisting the Clinical Lead in all operational activities of assigned clinical studies.
Responsibilities: Ensure timely execution of clinical studies in accordance with all applicable regulatory requirements and in compliance with SOPs and GCP/ICH guidelines. Provide guidance to CRO/external service providers in their day-to-day operational activities to ensure compliance with study protocol and in accordance with agreed scope of work. Ensure smooth functioning of study team meetings with CROs/vendors by reviewing meeting agenda, materials, and minutes in a timely manner. Oversee CRO study start-up activities and provide timely input to study-specific plans (e.g., site monitoring plan) and ensure that essential site documents are collected and sites are initiated per plan. Work with CRO and study team to help identify, select, and monitor performance of investigational sites for clinical studies, review all monitoring visit reports from CRO and identify areas of concern and escalate to Supervisor in a timely manner. Coordinate with the CRO to successfully execute key study meetings such as Investigator Meetings and/or site initiation visits and ensure proper storage and shipment of samples to the designated laboratory. Review and approval of investigational product (IP) release packages and management of IP accountability and reconciliation process with the CRO. Interact with investigators, site staff, and study team members in a professional, ethical, and timely manner to ensure smooth communication within study/project team. Review study data on an ongoing basis to ensure accuracy and integrity, review and assist in successful closing of data queries to ensure timely database lock. Interact with CRO to ensure completeness of Trial Master File on an ongoing basis. Other responsibilities as assigned by the Supervisor.
Education, Experience, Knowledge and Skills: Bachelors degree is required, preferably in a science related field. Minimum 5 years of clinical operational experience including at least 3 years of clinical study manager experience is required. Experience in conducting Pharmacokinetic studies is strongly preferred. In-depth knowledge of regulatory requirements and GCP/ICH guidelines is required. Strong attention to detail and ability to work independently and in collaboration within a cross-functional team environment is required. Strong oral and written communication, project management, and computer (MS Project, Word, Excel, PowerPoint, Outlook, etc.) skills are required.
Work Conditions: This job operates in a professional corporate office setting. Domestic travel up to 20% may be required.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.