# Clinical Research Manager **Company**: IQVIA **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/So-Paulo-Brazil/Associate-Study-Start-Up-Manager_R1555532-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_21036cfc-cb0 ## Description Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Responsibilities: - Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. - Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. - Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. - Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. - Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. - Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. - Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations. - Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. - Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. - Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. - Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). - Mentor and coach colleagues as required. - Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. - May take a lead role in developing long standing relationships with preferred IQVIA customers. - Deliver presentations/training to clients, colleagues and professional bodies, as required. - May be involved in activities related to monthly study budget planning and reviews. Qualifications: - Bachelor's Degree Life sciences or related field - 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. - Strong negotiation and communication skills with ability to challenge. - Excellent interpersonal skills and strong team player. - Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects. - Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process. - Demonstrated proficiency in using systems and technology to achieve work objectives. - Good regulatory and/or technical writing skills. - Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines. - Good leadership skills, with ability to motivate, coach and mentor. - Good organizational and planning skills. - Ability to exercise independent judgment taking calculated risks when making decisions. - Good presentation skills. - Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors. - Excellent understanding of study financial management. - Proven ability to work on multiple projects balancing competing priorities. ## Skills ### Required - Clinical Practice (GCP) - International Conference on Harmonization (ICH) - regulatory affairs - clinical trials management - leadership - communication - project management --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/So-Paulo-Brazil/Associate-Study-Start-Up-Manager_R1555532-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)