# Global Study Associate Director **Company**: IQVIA **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Buenos-Aires-Argentina/Global-Study-Assoc-Director---Single-Sponsor-Dedicated_R1571828?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_60e929c8-2ed ## Description The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. **Essential Functions** - Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. - Lead and facilitate communication across all functions, including external partners and service providers. - Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs. - Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. - Develop and maintain relevant study plans including required input into study level quality and risk management planning. - Accountable for ensuring that information in all systems utilized at a study-level are current and accurate. - Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational). - Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones. - Oversee Trial Master File (TMF) completion in accordance with relevant SOPs. - Ensure timely compliance with company-wide governance controls. - The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle. - Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines. - Provide regular feedback on individual performance to the study team members and their line managers to support their professional development. **Qualifications** - University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. - 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience. - Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development. - Demonstrated solid project management skills and knowledge of relevant tools. - Strong, demonstrated abilities/skills in team leadership. - Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders. - Excellent communication and interpersonal skills. - Strong strategic and critical thinking abilities. - Strong organizational and problem-solving skills. - Ability to manage competing priorities. ## Skills ### Required - ICH-GCP - clinical research regulatory requirements - clinical study management processes - project management - team leadership - communication and interpersonal skills --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Buenos-Aires-Argentina/Global-Study-Assoc-Director---Single-Sponsor-Dedicated_R1571828?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)