The Principal Central Monitor will perform remote study 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 all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of statistical and analytical tools. In addition, the Principal Central Monitor will assess site, study and portfolio data quality, risks and trends as well as operational performance and summarize the findings for Project Lead, Functional Lead and/or sponsor review and action planning.   Performs all tasks routinely and independently, with minimal guidance. May provide support to CMs including training and mentoring. May review and approve of reports or serve as a leader of the CMs on the project team.

JOB RESPONSIBILITIES

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety. 
• Immediately communicates/escalates serious issues to the project team and, with guidance, develops action plans.
• Documents observations noted during reviews, investigates trends, issues and risks for root cause.
• Creates action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
• Actively participates in initial risk assessments and suggest various anticipated study specific risks.
• Reviews Monitoring Plan and suggest strategies.
• Set-up and/or provide inputs needed for setting-up analytics tools.
• Maintains expert knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages study- and portfolio-level activities to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve 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.
• Performs QTL reviews.  With support from cross-functional team, facilitates discussions on any mitigations or changes needed to functional plans.  Is responsible for tracking Quality Tolerance Limits reviews, results and mitigations.
• Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation of the most relevant and actionable items for interpretation by Project Leads, Sponsors and other functional roles assigned follow-up.

QUALIFICATION REQUIREMENTS 

• Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
• Expert in Risk-Based Monitoring Strategies processes and tools preferred.
• Expert in Integrated Quality Risk Management (IQRM) theories.

• Must demonstrate strong computer skills and be able to embrace new technologies.
• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).
• Mastery of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers).
• Strong analytical skills.

• Developed therapeutic expertise.
• Excellent verbal and written communication skills.
• Excellent presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Strong time management, technical and organizational skills.
• Ability to work independently and within a team environment.
• Strong problem-solving skills
• <20% travel (limited to trainings, investigator meetings, sponsor meeting).

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing 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 comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.