Centralized Monitor, Cairo, Egypt

4 hours ago

مصر, Egypt IQVIA Full time

Job Overview
- Essential Functions
- 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 study(ies).
- 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 study(ies). (CM-Study)
- 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
- Qualifications
- Bachelor's Degree Bachelor’s degree in clinical, life sciences, or related field, or nursing qualification.
- Requires minimum of 1 year of relevant work experience or equivalent combination of education, training and experience.
- Experience in clinical research field preferred.

Skills and Abilities
- Strong written and verbal communication skills including good command of English language.
- Good command of German or French language.
- Good Clinical system expertise.
- 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.

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