sr Central monitor iSyneos Health
Workplace: MetroManila, Manila, Pasig
Salary: Agreement
Work form: Full time
Posting Date: 09/11/2025
Deadline: 17/01/2021
The Senior Central Monitor (Sr. CM I) will perform 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 all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of technologies. In addition, the Sr. CM I will assess site data quality, risks and trends as well as operational performance and summarize the findings for CRA review and action planning. Performs all tasks routinely and independently, seeking guidance as needed.
Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
Assesses factors that might affect subject/patient's safety and clinical data integrity 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 action plans.
Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action 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 dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.
Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
For assigned activities, understands CM project scope, budgeted hours, and timelines; manages patient- and site-level activities assigned to CM in the clinical or central monitoring plans to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt, with the oversight of the Lead CRA/Central Monitoring Lead (CML), 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.
Assesses site data quality, risks and trends as well as operational performance and summarizes the findings for CRA review and action planning.
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 CRAs and other functional roles assigned follow-up.
Qualifications
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
3 years of clinical monitoring or central monitoring experience
Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
Must demonstrate good 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).
Excellent verbal and written communication skills to relate to internal stakeholders.
Able to inform, influence and communicate cross-functionally.
Strong analytical skills.
Developed therapeutic expertise.
10% travel (limited to trainings, investigator meetings).
Syneos Health
Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
Assesses factors that might affect subject/patient's safety and clinical data integrity 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 action plans.
Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action 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 dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.
Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
For assigned activities, understands CM project scope, budgeted hours, and timelines; manages patient- and site-level activities assigned to CM in the clinical or central monitoring plans to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt, with the oversight of the Lead CRA/Central Monitoring Lead (CML), 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.
Assesses site data quality, risks and trends as well as operational performance and summarizes the findings for CRA review and action planning.
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 CRAs and other functional roles assigned follow-up.
Qualifications
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
3 years of clinical monitoring or central monitoring experience
Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
Must demonstrate good 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).
Excellent verbal and written communication skills to relate to internal stakeholders.
Able to inform, influence and communicate cross-functionally.
Strong analytical skills.
Developed therapeutic expertise.
10% travel (limited to trainings, investigator meetings).
Syneos Health
Other Info
Pasig City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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Syneos Health
About the company
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