Job Description Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability. This role can bebased at our UK Head Office situated in Uxbridge or fully homebased in the UK, we are near to Uxbridge train station as well as the town centre and the building has plenty of free parking. The office is open planned, andyou will be working in aninnovative and collaborative environment. As the Senior Observational Research Specialist you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations. Responsible for supporting the development of the Clinical Operations service delivery within Parexel. Accountabilities: Depending on study assignment and with support as necessary key accountabilities can include: – Primary contact for assigned sites and build positive business relationships with physicians and site staff. – Site identification, selection and start-up activities including negotiation of site agreements and budgets. – Demonstrate protocol expertise. – Customization of country/site specific documentation. – Conduct of all remote and on-site monitoring activities through all study stages. – Proactive issue management with a focus on issue prevention. – Identification of potential out of scope activities. – Perform regular reviews of data according to Site Management Plan (SMP). – Responsible for the completeness and quality of the site files for the assigned sites. – Maintain study management system(s) on a daily basis. -Coordination of a team of ORSs managing a study in a country/ region (language dependent) and main point of contact for the ORL. – Regularly inform manager, ORL and PL (as needed) of status of work. -Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures. – Coaching and mentoring of new and/ or junior staff members. – Assessment of junior staff including shadow/ assessment of calls/ visits as part of ORS Certification activities. – Contribution to department service delivery and participation in initiatives. Qualifications Education: – Degree in a life science, nursing qualification or other relevant experience required. Skills: – Excellent interpersonal, verbal and written communication skills in English (and local language as necessary). – Excellent customer focus and able to interact professionally with a client organization and study site. – Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial Management and EDC systems. – Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP. – Ability to work in a’virtual’ team environment as well as work independently, seeking guidance as appropriate. – Ability to manage complex workload (across multiple studies as necessary) and prioritize accordingly. – Consistently delivers work to’First Time Quality’ whilst managing time effectively to meet metrics and/or team objectives. – Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines. – Willing to travel locally and internationally as necessary. – Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery. – Effectively applies knowledge to provide advice or solutions based on expertise and experience. – Ability to provide support and constructive feedback to study team members and Dept. colleagues. Knowledge and Experience: – Strong & relevant clinical operations knowledge and work experience preferred, operating as either an experienced CRA or Study Start Up Specialist – Must have previous knowledge and experience working in Observational Research Services or Non-interventional research studies. In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salaryas well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type Apply today to begin your Parexel journey! Why Work at Parexel There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.
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