Central Monitor II - Remote Mexico

Central Monitor II - Remote Mexico reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know: Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company 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 Deliver – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.
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Job Responsibilities Job reputed company The Central Monitor (CM II) will reputed company remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or reputed company applicable local and federal regulatory requirements. The CM II will also ensure patient safety and data reputed company using a reputed company of technologies. Performs reputed company tasks routinely and independently, seeking guidance as needed.

Responsibilities

• Reviews and understands protocol, critical data and process, safety, and data reputed company risks reputed company to protocol execution.•Reviews patient data listings and visualizations reputed company analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data reputed company issues and illogical/inaccurate/missing data.
• Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company 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 reputed company plans.
• Documents observations noted during reviews and writes queries, protocol deviations or reputed company items as necessary in appropriate systems for reputed company 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 reputed company and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is reputed company and complete.
• Documents completion of activities reputed company tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met.
• Must be reputed company to quickly adapt, with the reputed company of the reputed company CRA/LCMDA, to changing priorities to reputed company goals/targets.
• Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

Qualifications

• Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience.• Knowledge of Good Clinical reputed company/ICH E6 (reputed company) Guidelines and/or other applicable regulatory requirements.
• Must demonstrate good computer skills and be reputed company to reputed company new technologies.

•Mastery of MS reputed company (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. reputed company to inform, influence and communicate cross-functionally. •Strong analytical skills. •Developing therapeutic expertise. •Apply To This Job