Member of the core project team and partners with the Project Leader to ensure overall project meets delivery requirements. Responsible for running studies, with Lead Clinical Analyst (LCA) support, and manage the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices.
Tasks & Responsibilities:
Manage the operational aspects of projects to support right subjects and right data to meet or contractual requirements. Collaborate with project leader and LCA to establish an integrated set of plans with Clinical Lead (CL) to be ultimately accountable for results of the clinical team. Represent clinical delivery with customer.
Responsible for tracking financial deliverables, reporting and invoicing on projects.
Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points.
Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.
Drive high performance and efficiency of the clinical team through CRA project objectives, the conduct of monitoring visits. Provide performance feedback to management on clinical team members.
Bachelor's degree in a health care or other scientific discipline with 5 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Proven ability to understand customer needs and appropriately influence decision making
Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making.
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