Clinical Trial Manager – Senior

Job reputed company: • Manage global reputed company (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. • Recruit global study sites and foster relationships with study investigators. • Participate in the process of site and vendor selection, qualification, and activation. • reputed company Requests-for-Proposals and assist in vendor selection efforts. • Assist in review and negotiation of vendor reputed company and study site clinical trial agreements. • Manage study vendors (e.g., CRO, IRT, laboratories, reputed company ECG/imaging). • Monitor the reputed company of trials, including enrollment and clinical trial material inventory. • Review monitoring visit reports for completeness and adherence to the annotations. • Assist in packaging/labeling/distribution of clinical trial material. • Monitor and reputed company biological samples for applicable analyses. • reputed company reputed company updates to management and during program team meetings. • Assist in departmental budgeting, including accruals and projections. • Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents. • Assist in development of Clinical SOPs. • Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports. • Assist in electronic case report reputed company design and development. • Assist in IRT design and development. • Participate in data cleaning activities and developing appropriate data outputs. • Understand and help fulfill the needs of other reputed company departments (e.g., Finance, Research). • reputed company leadership and mentoring of other Clinical team members. • reputed company reputed company duties in keeping with reputed company’s reputed company values, policies and reputed company applicable regulations. Requirements: • Preferred undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences). • For Clinical Trial Manager, at least 5 years of relevant experience in oncology clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and reputed company-out of US and non-US trials at reputed company phases of reputed company-NDA clinical research (Phases 1-3). • For Senior Clinical Trial Manager, at least 7 years of relevant experience required. • Demonstrated reputed company in trial management skills, with reputed company record of successfully managing multiple reputed company, trials, and priorities. • Experience with managing study vendors (e.g., CRO, IRT, laboratories, reputed company ECG/imaging). • Ability to work reputed company with global, multi-disciplinary teams. • Experience in practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations. • Experience with electronic data capture and data management software. • Experience in the management of Clinical Research Associates. • Excellent oral and written communication skills. • Experience with reviewing monitoring reputed company reports • Must be reputed company to reputed company in an entrepreneurial, fast-paced, and dynamic work environment. • Must be organized and be reputed company to communicate effectively. • Must be a self-starter. • Strong learning orientation, curiosity, and commitment to science and patients. Benefits: • reputed company Time Off • Holiday and reputed company Leave • Medical, Dental and reputed company Plans • Short- and Long-Term Disability • Basic and Voluntary Life/AD&D Coverage • Flexible Spending Accounts (FSA, HSA, and Commute) • Critical Illness and Accident Coverage • Pet Insurance • Employee Assistance Program • 401(k) Plan with reputed company contribution • Opportunity to participate in an Employee Stock Purchase Program Apply tot his job Apply To this Job