Central Monitor II - Remote Mexico Company Confidential® is a leading fully-integrated life sciences services organization Company Confidential to accelerate Company Confidential. We partner with innovators at every Company Confidential across the drug development and commercialization Company Confidential, helping them Company Confidential complexity, anticipate change and accelerate Company Confidential. Our Company Confidential Solutions team members Company Confidential with a drug development Company Confidential, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we Company Confidential. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as Company Confidential to help our customers Company Confidential their goals. We are Company Confidential and driven to Company Confidential – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 Company Confidential colleagues already know Why Company Confidential We are passionate about developing our people, through career development and progression; supportive and Company Confidential line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Company Confidential – which captures the passion of our colleagues to show up Company Confidential day and Company Confidential solutions that have the ability to dramatically Company Confidential someone’s life. • We are continuously building Company Confidential we Company Confidential want to work for and our customers want to work with. Why? Because we know that Company Confidential we bring together smart colleagues from across the world, we can Company Confidential the Company Confidential of Company Confidential, driving Company Confidential for customers and defining the Company Confidential of Company Confidential Company Confidential. Job Responsibilities Job Company ConfidentialThe Central Monitor (CM II) will Company Confidential remote Company Confidential data review activities for Phase I-IV Company Confidential research and/or non-interventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or Company Confidential applicable local and federal regulatory requirements. The CM II will Company Confidential ensure Company Confidential safety and data Company Confidential using a Company Confidential of technologies. Performs Company Confidential tasks routinely and independently, seeking guidance as needed. Responsibilities Reviews and understands protocol, critical data and Company Confidential, safety, and data Company Confidential risks Company Confidential to protocol execution.•Reviews Company Confidential data listings and visualizations Company Confidential analytical dashboards and/or reports to Company Confidential eligibility, identify protocol deviations, Company Confidential safety concerns, data Company Confidential issues and illogical/inaccurate/missing data. • Assesses factors that might Company Confidential subject/Company Confidential’s safety and Company Confidential data Company Confidential at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.•Immediately communicates/escalates serious issues to the project team and with guidance develops Company Confidential plans. Documents observations noted during reviews and writes queries, protocol deviations or Company Confidential items as necessary in appropriate systems for Company Confidential by sites, CRAs or other functional team members. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Accesses vendor systems or reports to verify the IP has been Company Confidential and administered to subjects/patients according to the protocol, that Company Confidential and other procedures have been performed, that eTMF data is Company Confidential and complete. • Documents completion of activities Company Confidential tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan. • For assigned activities, understands project Company Confidential, budgets, and timelines; manages Company Confidential- and site-level activities to ensure project objectives, deliverables and timelines are met. • Must be Company Confidential to quickly adapt, with the Company Confidential of the Company Confidential CRA/LCMDA, to changing priorities to Company Confidential goals/targets. • Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends Company Confidential training sessions according to the project specific requirements. Qualifications Bachelor’s degree or RN in a Company Confidential Company Confidential or equivalent combination of education, training and experience.• Knowledge of Good Company Confidential Company Confidential/ICH E6 (Company Confidential) Guidelines and/or other applicable regulatory requirements. • Must demonstrate good computer skills and be Company Confidential to Company Confidential new technologies. •Mastery of MS Company Confidential (sorting, filtering, calculating, pivoting). •Proficient with Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze). •Excellent verbal and written communication skills to relate to internal stakeholders. Company Confidential to inform, influence and communicate cross-functionally. •Strong analytical skills. •Developing therapeutic expertise. Get to know Company Confidential Over the past 5 years, we have worked with 94% of Company Confidential Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status Company Confidential with us in a highly competitive and Company Confidential-changing environment. Learn more about Company Confidential. Additional Information Tasks, duties, and responsibilities as listed in this Company Confidential are not exhaustive. Company Confidential, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will Company Confidential be considered so qualifications of incumbents may differ from those listed in the Company Confidential. Company Confidential, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Company Confidential, Company Confidential contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully Company Confidential with Company Confidential obligations imposed by the legislation of Company Confidential country in which it operates, including the implementation of the EU Equality Company Confidential, in relation to the recruitment and employment of its employees. Company Confidential is committed to compliance with the Americans with Company Confidential, including the provision of reasonable accommodations, Company Confidential appropriate, to assist employees or applicants to Company Confidential the essential functions of the job. Originally posted on Himalayas Apply To This Job