Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Senior Observational Research SpecialistJob ID 53865BR United Kingdom - Any Region - Home Based
This role can be either home based in the UK or at our UK Head Office situated in Uxbridge, 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, and you will be working in an innovative 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. You will also be responsible for supporting the development of the Clinical Operations service delivery within Parexel.
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.
- 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.
- Degree in a life science, nursing qualification or other relevant experience required.
Knowledge and Experience:
- Clinical Monitoring, Data Management, Clinical Operations and/or research experience with a solid understanding of Observational/ Non-interventional research methodology and terminology.
- We will also consider applications from Academia in a Research Associate position but ideally you would have worked in the CRO industry preferably in the capacity as a CRA, Study Start Up Specialist or Data Management Lead.
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 salary as 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!
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