Clinical Project Coordinator, Iqvia Biotech

Job Overview IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas agile structure collaborative culture and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster The Clinical Project Coordinator supports with minimal supervision the Project Leader PL and Clinical Project Manager CPM with project management activities to ensure all work is conducted in accordance with standard operating procedures SOPs policies and practices good clinical practices GCP applicable regulatory requirements and meets quality timeline metrics Ensure customer satisfaction is met in relation to assigned project s Essential Functions Assist in the establishment and maintenance of all project documentation including all files records and reports according to the scope of work and standard operating procedures SOPs Assist with periodic review audit of files for accuracy and completeness Assist with the coordination and tracking of all information communications documents materials and supplies for assigned projects Manage study specific eTraining and oversee compliance Support the updating and maintenance of internal systems databases tracking tools timelines and project plans with project specific information Prepare and distribute status tracking and project finance reports and assist the project manager s with budget allocation and approval of invoices Organize and support project leader PL in managing internal study team and customer meetings Take and record minutes notes and actions at assigned meetings distribute and follow up accordingly Support the preparation of presentation materials for meetings internal external and project summary data Support the coordination of project team and or customer meetings including logistics and materials required Identify and escalate discrepancies in project tracking data timesheet coding expense data billing etc Establish and manage performance dashboards analyze event triggers and alerts and determine appropriate follow up for PL or others to act upon Monitor metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management Assist in the establishment and maintenance of all project documentation including all files records and reports according to the scope of work and SOPs Coordinate onboarding of new Key Members and system access Assist in the training and orienting of more junior project support staff Qualifications Bachelor s Degree in life sciences or other related field required Good knowledge within a specific discipline typically gained through extensive work experience and or education 3 - 4 years experience or equivalent combination of education training and experience Knowledge of clinical trials - basic knowledge of applicable clinical research regulatory requirements i e Good Clinical Practice GCP and International Conference on Harmonization ICH guidelines Knowledge of clinical systems such as CTMS and experience with Trial Master File TMF filing Experience with EAC reporting preferred Strong written and verbal communication skills including good command of English language Good communication and interpersonal skills Good problem solving skills Results and detail-oriented approach to work delivery and output Good planning time management and prioritization skills Attention to detail and accuracy in work Good software and computer skills including MS Office applications Ability to establish and maintain effective working relationships with co-workers managers and clients Ability to work across geographies displaying high awareness and understanding of cultural differences IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at https jobs iqvia com