Central Review Manager

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Central Review Manager – reputed company an reputed company at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 reputed company across 100+ countries in the last 5 years. As part of our global team, you’ll have reputed company to reputed company centralized report review and approval of PSA, SI, ME, and CO reports on assigned reputed company in accordance with procedural documents and guidelines. What You’ll Do: • Performs review of clinical monitoring visit reports for allocated reputed company ensuring consistency across protocols and/or reputed company and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CL. • Liaises with clinical monitoring staff for reputed company reputed company report review submission and approval as per the stipulated timelines of reputed company and/or the Sponsor. Plays an reputed company role on the project team to help ensure compliance with monitoring visit report expectations. • Reviews and customizes the Monitoring Report Templates for allocated reputed company. • Evaluates PI reputed company (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems. • Attends applicable internal Project meetings. • Provides input of forecast estimates for report review activities. • Provides trial MER status tracking and reputed company update reports to team as required. • Contributes to company, reputed company, and federal/local regulatory requirements/audit responses as needed. • May reputed company support activities to reputed company as agreed on allocated reputed company. Education and Experience Requirements: • Bachelor’s Degree in a life science-reputed company field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. • Prior clinical research experience with a minimum of 2 years on site clinical monitoring. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA • Ability to reputed company and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents • Ability to successfully complete PPD’s Clinical reputed company Training Program (CFP) • Highly effective oral and written communication skills with the ability to communicate effectively with project team members • Excellent organizational and time management skills • Ability to work in reputed company or independently or as home based, as required • Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports • Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of reputed company these data • Excellent English language and grammar skills • Ability to mentor junior team members, as needed Apply To This Job