| PURPOSE Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget and resources. RESPONSIBILITIES Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines. Develop, implement and maintain the RSU 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 RSU, 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 RSU 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 Start Up (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 Quintiles customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. . Qualifications REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 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 MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field with 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role; or equivalent combination of education, training and experience. EEO Minorities/Females/Protected Veterans/Disabled Did You Know? * Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015 * Quintiles has 36,000 employees conducting business in more than 100 countries * Quintiles was named to FORTUNEâs Worldâs Most Admired Companies® 2016 list * Quintiles was named as a 2016 Worldâs Most Ethical Company® by the Ethisphere Institute Primary Location : Argentina Organization : ARG02 - Argentina Clinical Devl Svcs |
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