Centralized Monitor

1 day ago

Bellville South, South Africa IQVIA Full time

JOB FAMILY DESCRIPTION

SUB-FAMILY DESCRIPTION

Using a unified monitoring platform, leads data integration, predictive and advanced analytics, and site & patient management

Executes and provides holistic and timely insights on patient, site, study, and program levels

Uses data insights delivered by innovative technology, enhanced processes and new roles to optimize execution to support capabilities, and site support capabilities to improve efficiencies and enhanced patient focus to deliver optimal project execution

SUMMARY

RESPONSIBILITIES
- Manage assigned studies under supervision.
- Attend study team meetings as needed or requested.
- Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
- Contribute to developing the study specific analytics strategy and/or work on developing advanced analytics. (CM-study)
- With guidance, provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
- Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders. (CM-study)
- Support CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
- Collaborate with and support project resources (CRAs/ CTAs/Centralized Monitoring team).
- Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
- Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned studies.
- In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data
- Performing the trend analytics for their respective studies. (CM-Study)
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.)
- Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team,
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan.
- Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk.
- Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed,
- Work in accordance of the Study Central Monitoring Plan.
- Establish and maintain effective project/ site level communications with relevant stakeholders.
- Maintain relevant project documents.
- Reviews reports per annotations, SOPs, guidelines etc, identifies issues and escalates the same to the CL, prepares annotations and conducts CRA trainings, conducts monthly SRS-CL calls to discuss major issues emerging from the trends noted during report review

**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
- Good Clinical system expertise.
- Strong written and verbal communication skills including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Understanding of clinical/medical data.
- Good motivational, influencing, coaching skills.
- Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
- Strong organizational and problem-solving skills.
- Effective presentation skills.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.

**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
- Bachelor's degree in life sciences or related field, or nursing qualification with 1 - 2 years of relevant clinical research experience or equivalent combination of education, training and experience.

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