Clinical Risk Management Director in Bucuresti

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. The Clinical Risk Management Director will be responsible for effectively directing the activities of RBQM (Risk Based Quality Management) across specific service lines, client projects, and staff in a manner that ensures all functions, projects, and tasks are handled with the highest quality, on time and within budget, in a manner consistent with SOP’s, regulations and ICON policies.Job DescriptionRecognize, exemplify and adhere to ICON's values which centers on Integrity, Inclusion, Agility and Collaboration• * As a Manager, the employee is expected to recognize the importance of and create a culture of quality in delivery and process improvement with a focus on optimizing and streamlining our processes, adding efficiency and value to our business and meeting client needs.Provide expert RBQM input into new business proposals, budgets and bid defense meetings as applicable.Review protocols and provide expert input into risk identification and associated mitigation strategiesReview and assess existing Risk Management SOPs, and components of other SOPs that relate to RBQM. Develop and review new Risk Management SOPs, drives and implements change management, process review & design as well as development of effective training, in line with ICON, Regulatory and Industry requirementsDrive innovation and continuous improvement in all areas of responsibility. Maintains awareness of evolutions in technology, sponsor and competitor positions as well as regulations affecting RBQM and lead/support working groups in initiatives for risk-based quality management or related process/system improvement. Drive, analyse and provide input for business cases for development projects in Risk Management or cross-functional projects involving Risk Management.Liaise with sponsors and cross-functional team members on project or program related matters where appropriate.Direct the effective management, development and performance review of staff within Risk Management. Lead succession planning.Excellent working knowledge of ICH E6 and ICH E8Travel (approximately 10%) domestic and/or internationalOther duties as assignedBenefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.