IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Provides leadership of the CMS team, in support of the project and clinical leader, and in collaboration with other functional teams, 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 our SOPs, policies and practices.
Partners with the CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation / guidelines and project Clinical Operations Plan (COP).
May perform functional lead responsibilities for assigned project deliverables for specific customers or projects / specified.
Should independently manage assigned global studies.
May attend study team and / or client meetings as needed or requested.
Contribute and / or oversee to the development and use of study management plans and / or DTE specific tools and templates and / or other study specific plans to evaluate the quality and integrity of the study.
Act as point of contact for assigned project deliverables.
May support project management team to develop monitoring strategy including monitoring triggers / thresholds.
Manage and monitor operational insight of the assigned project(s) and complete / oversee 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.).
May 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.
Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders.
Implement continuous improvement activities for assigned projects.
Manage project resources (CRAs / CMs / CTAs / CASs)
May perform and oversee the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import / export licences etc).
Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready.
May contribute in maintaining strong relationship with the stakeholders
May act as mentors or coaches for junior staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements;
i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Strong written and verbal communication skills including good command of English language.
Results and detail-oriented approach to work delivery and output.
Excellent motivational, influencing, negotiating and coaching skills
Ability to work on multiple projects and manage competing priorities.
Strong organizational, problem solving and decision making skills
Effective presentation skills.
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
To lead team and effectively work in team.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and min 4 years with relevant clinical research experience; or equivalent combination of education, training and experience
At least 4 or 5 years of relevant clinical monitoring experience
Advance English level (Mandatory)