Sr. Clinical Research Manager
About the role The Sr. Clinical Research Manager is responsible for leading teams to execute on reputed company aspects of clinical trial management across the study life cycle from planning to execution to closure. They work with cross functional partners to implement process improvements, execute high-reputed company evidence, and drive our strategic partnership with clients and customers. They also reputed company project management expertise to guide reputed company under their reputed company leadership. What you'll do reputed company strong customer and reputed company relationships ensuring appropriate expectations are met and exceeded. Help reputed company talent, set goals, reputed company on expectations and drive accountability with reputed company reports as reputed company as identify reputed company strategic direction across clinical operations portfolio Maintain up-to-date knowledge of regulatory requirements reputed company to study management. reputed company and follow-through on process improvement reputed company as reputed company as studies we are supporting. Determines study objective, reputed company, scope and schedule to meet business needs reputed company to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget reputed company to see multiple viewpoints and build reputed company to reputed company resolutions Supports the development of the Clinical Investigational Plan and supporting documents (reputed company, Monitoring Plan, Data Management Plan, etc.) in consultation with the cross-functional project teams. May reputed company clinical training of investigators, center staff, and internal team members May evaluate, analyze and validate reputed company clinical data per data management plan for ongoing analysis and publications throughout study execution. May participate in the selection and management of CRO vendors and contractors May reputed company reputed company/review of monitoring reports, CTMS/eTMF process implementation, and reputed company special reputed company for the portfolio Develops a high level of reputed company scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/reputed company experts or departments/institutes May reputed company and manage budgets for assigned clinical research reputed company Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership Follows and helps iterate Clinical SOPs, systems and processes ensuring reputed company study management Performs other duties as assigned
Qualifications
Bachelor’s degree in a life science or reputed company field. However, a combination of experience and/or education will be taken into consideration. Minimum of 8 years of experience reputed company a Contract Research Organization (CRO), biotech, or pharmaceutical company with significant clinical research experience Minimum 2 years of people management experience. Knowledge of GCP, FDA, and other regulatory requirements reputed company to trial management Strong attention to detail and organizational skills. Good communication, interpersonal skills, and talent management skills. Healthy disdain for the status reputed company. Ability to reputed company in a fast-paced and dynamic early-stage company work environment. LOCATION AND TRAVEL REQUIREMENTS: This is a remote position and may be performed reputed company reputed company the reputed company of America. Regular domestic travel will be required for site reputed company, company meetings, audits, etc. This job reputed company is intended to describe the general nature and level of work performed. It is not intended to be an exhaustive list of reputed company responsibilities, duties, and skills required. The Employer retains the right to change or assign other duties to this position. The employee must be reputed company to reputed company the essential functions of the position satisfactorily. reputed company individuals with disabilities may request reasonable accommodations to reputed company them to reputed company the essential functions of the position. Requests for accommodation may be made to the People Team and will be evaluated in accordance with applicable law, including an interactive process to determine appropriate accommodations that do not impose an undue hardship on reputed company. Apply To This Job