Central Monitor II
Location
Mexico
Posted
10 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Central Monitor II
Syneos Health
Role Description The Central Monitor (CM II) 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. The CM II will also ensure patient safety and data integrity using a variety of technologies. 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 project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, 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. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and 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). - 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. Able to inform, influence and communicate cross-functionally. - Strong analytical skills. - Developing therapeutic expertise. - <10% travel (limited to trainings, investigator meetings). Additional Information 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.
Related Guides
Related Categories
Related Job Pages
More Risk Jobs
• Lead the preparation, authoring, review, and updating of Risk Management Plans (RMPs) for regulatory submissions and post-approval activities. • Develop RMPs in support of Marketing Authorisation Applications (MAAs) and variations. • Ensure RMPs comply with regional pharmacovigilance and regulatory requirements. • Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality. • Provide strategic pharmacovigilance input regarding safety concerns, risk minimisation measures, and pharmacovigilance activities. • Support responses to health authority questions related to risk management and pharmacovigilance documentation. • Contribute to the continuous improvement of pharmacovigilance processes and documentation standards.
Role Description We are looking for a detail-oriented Data Steward to own the integrity of our enterprise data. In this role, you will be the frontline defender of Data Quality, implementing rigorous monitoring and remediation processes to eliminate silos. You will manage the lifecycle of our master data, ensuring compliance with Data Governance policies while working directly with technical teams to optimize our MDM hubs. If you have a passion for precision and thrive on organizing complex information, you’ll fit right in. Responsibilities - Manage and maintain the "Golden Record" for core data domains (Customer and Product), including resolving data conflicts and duplicates. - Manage data hierarchies, relationships, and cross-system mapping. - Oversee the matching and merging process to improve consolidation of data. - Establish, measure and monitor Data Quality KPIs (Accuracy, Completeness, Timeliness, Consistency). - Perform root-cause analysis on data discrepancies and lead remediation efforts. - Design and implement automated data profiling, validation and cleansing processes. - Support the development of data governance standards, policies, and business rules. - Document data lineage, business glossaries, and data dictionaries. - Facilitate data stewardship activities across business units. Qualifications - 3-5 years of experience in data management, data stewardship, or related roles. - Strong SQL skills for data profiling and analysis. - Strong understanding of Master Data Management concepts and best practices. - Experience with data quality tools and methodologies. - Familiarity with data visualization tools to report on data quality metrics. - Proficient understanding of data lifecycle management and data modeling concepts. - Excellent communication skills in English; the ability to explain technical data issues to non-technical stakeholders. Desired Qualifications - Familiarity with MDM platforms (Informatica, Reltio, Stibo, etc.). - Foundation in Data Governance methodologies and foundations. - Experience with Cloud Data Warehouses (Snowflake, BigQuery, or Databricks). - Knowledge of industry-specific data standards. Location This role will be remote, and based in Colombia. Travel For this role, you may be required to travel occasionally to participate in project or team in-person meetings. Benefits - Competitive pay. - Generous time off. - Ample parental and wellness leave. - Healthcare. - Retirement savings program. - Offerings vary by location.
• Lead the development of policies, processes, and structures that guide and oversee activities such as research design, data collection, analysis, and dissemination. • Collaborate with research consortia, scientific working groups, and institutional partners to ensure the ethical, responsible, and accountable conduct of research and data sharing. . Design, implement, and champion governance systems that protect the rights and welfare of research participants and preserve the integrity of the scientific process. • Lead initiatives that enable responsible data sharing by evaluating data sensitivity, and designing and applying governance approaches, such as data access controls . Lead the assessment of emerging privacy considerations and develop or update compliance methods to address current needs. (This is not a data engineering or analytics role.) • Ensure adherence to ethical, legal, and institutional requirements. Contribute to incident investigations and the implementation of corrective actions/preventative action (CAPA) plans. Monitor activities and report to stakeholders. • Lead research, scientific community, and data governance initiatives addressing and enabling the responsible application of AI and other developing technologies. Promote the use of AI tools for documentation, process improvement, and novel uses within the governance field. • Lead the development and implementation of standards for data sharing and governance education. Develop and sustain new governance protocols and disseminate/socialize updated standards through training materials and presentations. • Lead governance partnerships with internal teams and external collaborators. Respond to data access requests and provide user support, as needed. Advise established research communities using standard or novel data sharing and governance framework approaches.
Role Description An exciting opportunity exists for a detail-oriented and motivated Risk Analyst to join a well-established company within the finance industry. Previous experience in private banking, home loans, or property finance is essential. - Assess and analyse applications in accordance with company credit policies - Review supporting documentation and request additional information where necessary - Prepare and present applications to credit for approval - Manage multiple applications and transactions simultaneously - Ensure accuracy, compliance, and adherence to deadlines throughout the process Qualifications - Previous experience in private banking, home loans, or property finance - Candidates with collections, conveyancing, or estate administration experience will also be considered - Knowledge of the Cape Town property market, along with established relationships within the conveyancing sector is highly advantageous - Excellent time management and prioritisation skills - Strong written and verbal communication abilities - Ability to multitask and manage multiple deals concurrently - High level of attention to detail and accuracy - Strong teamwork and collaboration skills - Ability to perform effectively under pressure in a fast-paced environment - Positive attitude and professional approach to work - Self-disciplined with the ability to work successfully in a hybrid environment - Able to follow instructions while taking ownership and initiative - Proficient in Microsoft Word and Excel Apply Email your application to: [email protected]
