AddressWe have a great role for an Implementation Specialist in Central/ West London. Our client has an extensive global network of sites they work with to provide clinical trials to a range of sponsors andmainly in cardiovascular, They have a platrofrm to run studies and need a great implementaion specialist to help with setting up projects in this system. Are you a graduate looking for an exciting role as an Implementation Specialist for a rapidly growing Clinical Research Organisation? If you have some experience with eDC this would be great.
Implementation Specialist will ensure studies are planned and implemented to the highest standards, ensuring the correct information is collected and that data is accurate and in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines.
Key Responsibilities:
Assist in defining and/or create data listings, summary table validation, data specifications and/or data transfers in preparation for statistical review and/or data management audit
Install and configure database management systems (DBMS) and related software and set up and maintain database instances, including user accounts, roles and security configurations
Work with data architects and developers to design and optimise database plan
Create and maintain comprehensive documentation of database configurations, procedures and best practices and create and update documentation regularly to facilitate knowledge sharing and operational efficiency
Collaborate with clients to understand requirements, challenges and objectives and develop and execute comprehensive implementation plans tailored to needs
Provide training and guidance to clients to ensure they can effectively use implemented solutions, create materials and documentation as needed
Conduct tests to ensure solutions meet quality standards and resolve issues or discrepancies
Plan and execute data migration strategies when necessary and integrate new solutions with existing systems and data sources, ensuring data integrity
Maintain a strong client relationship to ensure continued success and provide support to clients, addressing questions, issues and optimisation needs
Oversee collection, integration and validation of clinical trial data
Oversee and input to database development being responsible for CRF design, annotation of CRF and data model, edit checks, access, locking and system UAT and validation
Develop Data validation/review specifications and perform verification and User Acceptance
Testing of configured databases
Responsible for data vendor collaborations and reconciliation of data from external sources
(e.g. Serious Adverse Events, IVRS, Central Laboratory) and participate in conference calls and/or meetings with vendors
Produce information/reports as appropriate and perform QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects
Report risks and meet with other functions to discuss data issues and input to process development and improvement
Other relevant duties as directed by management
Desired Skills and Experience:
Bachelor's degree or similar education in computer science, IT or a related field
Essential that the job holder can work with close attention to detail, scrutinise the validity of data and can phrase data queries in a clear, impartial and non-technical manner
Ideal Skills and Experience:
Java Script and/or other scripting languages for automation (experience ideal, candidates will be trained)
Work experience in a database development/implementation role and /or other related work experience in a medical device or pharmaceutical industry/company is ideal, not necessary
Experience in implementing and integrating software solutions or technologies, or working knowledge of Clinical database applications such as EDC, CTMS, Rave, IVRS, is ideal not necessary
IT and Clinical Support, Technical Support, Helpdesk, Desktop and Servers experience - Ideal, not necessary
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