The primary role of the Associate Clinical Operations Processes and Systems is to support end users of ClinOps systems and performing central system health checks. The Associate Clinical Operations Processes and Systems will collaborate with the Lead ClinOps Processes and Systems to evaluate and drive improvements to business processes and systems. The Associate Clinical Operations Processes and Systems helps to ensure the efficiency of business operations by supporting the creation and implementation of changes or improvements as needed. The Associate Clinical Operations Processes and Systems supports with the generation of documentation of existing processes, systems and improvements, forecasting expected results of process changes and analyzing implemented changes.
Main activities are:
Provide general end user support (level 0) and partner with Business Information Systems (BIS) and/or external vendors when additional support (level 1-3) is needed
Support inspection readiness activities
Evaluate existing business processes and systems and identify areas in Clinical Operations where efficiencies/processes and tools can be developed or refined to better support the business
Support the analysis of potential solutions to improve processes and systems
Review existing systems and/or new software applications, by attending system demos, and in close collaboration with BIS
Assist in making business decisions relating to system implementation, modification, maintenance, etc.
Support the design, development and implementation of business processes/systems to achieve organization goals
Act as System Business Owner delegate for system testing and/or system access request
Support the roll-out of business processes and systems and provide continuous support such as updating/creating applicable procedural documents, training, questions and answers trackers, etc.
Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system.
This includes: maintenance of product records, picklist values, EDL Master Templates, the TMF index and Document Templates, bulk updates of metadata fields of documents and expected documents, application of self-evident corrections in metadata, and the user access review.
Comprehensive knowledge/expertise and keeping current guidance and best practices on ICH GCP guidelines, and applicable regulations.
Support initiatives for continuous business process/system improvements
If applicable: Named Clinical Archivist: responsible for the archiving of clinical trials and back-up archivist for the internal and external physical archives.
Qualifications
Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
Minimum of 1 year of experience in Clinical Operations
Experience with Veeva Vault, eTMF, CTMS, eDC, IRT, software used for data analytics and visualisation (eg Tableau), etc is a plus
Experience with working in an outsourced model is a plus
Knowledge of ICH-GCP and other applicable legislation to ensure good quality processes and validated systems
Knowledge of the overall clinical trial processes
Experience with tools and systems used to manage and execute clinical trials
Detail-oriented problem-solver with an analytical mindset
Able to work effectively both independently and in teams
Able to work with people of diverse backgrounds
Solid verbal and written communication skills
Interpersonal skills with ability to communicate effectively across different levels of the organization
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.