Leader of the Centralized Monitoring team, partner with the project and clinical lead to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract, while optimizing speed, quality and cost of delivery and in accordance with IQVIA SOPs, policies and practices.
Essential Functions :
Leadership activities :
Leader of the Centralized Monitoring team, partner with the project and clinical lead to perform oversight on clinical deliverables on global assigned projects as per the protocol, SOPs, respective regulation / guidelines and project Clinical Operations Plan.
Unblinded CL, including IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import / export licences etc).
May act as CL when CL role is not assigned to the study.
May act as CL at project close out.
Manage project resources (CRAs / Central Monitors / Clinical Trial Assistants / Centralized Monitoring Assistants).
Attend study team and / or client meetings.
Development and use of study management plans, and / or RBM specific tools and templates, and / or other study specific plans to evaluate the quality and integrity of the study.
Support project management team to develop monitoring strategy, including monitoring triggers / thresholds.
Analytical activities :
Manage, monitor and complete 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 compliance etc.).
Contribute to developing the study specific analytics strategy and work on developing advanced analytics.
Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready, including eTMF oversight.
Mentors or coaches for junior staff.
Bachelor's degree in life sciences or related field.
i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Strong written and verbal communication skills including advanced command of English (Mandatory).
Strong organizational, problem solving and decision making skills.
Results and detail-oriented approach to work delivery and output.
Excellent motivational, influencing, negotiating and coaching skills.
Ability to work on multiple global projects and manage competing priorities.
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
To lead team and effectively work in team.