Clinical Operations Processes and Systems Associate

​An brilliant opportunity has arisen for an Clinical Operations Processes and Systems Associate to provide support for clinical operations (CO) system end users and conduct central system assessments. The successful candidate will collaborate with the Lead CO Processes and Systems to assess and drive improvements in business processes and systems. Ensuring operational efficiency, you will aid in implementing necessary changes or enhancements and contributes to documenting existing processes, systems, and advancements.

Roles and Responsibilities:

·         Offer general end user support and collaborate with Business Information Systems (BIS) or external vendors for additional support (level 1-3)

·         Assist in inspection readiness activities

·         Evaluate current business processes and systems to identify areas in Clinical Operations for enhanced efficiencies and tools

·         Support the analysis of potential solutions to enhance processes and systems

·         Review existing or new software applications, attend system demos, and collaborate with BIS for system assessment

·         Aid in making business decisions regarding system implementation, modification, and maintenance

·         Assist in designing, developing, and implementing business processes/systems to meet organizational goals

·         Act as System Business Owner delegate for system testing and/or access requests

·         Support the rollout of business processes/systems and provide continuous assistance like updating procedural documents, training, and Q&A trackers

·         Function as the Business Administrator in the eTMF system, maintaining records and supporting close-out activities

·         Maintain comprehensive knowledge of ICH GCP guidelines, best practices, and applicable regulations

·         Support initiatives for continuous improvement in business processes/systems

·         If applicable: Serve as a Named Clinical Archivist responsible for clinical trials archiving and as a back-up archivist for physical archives

Candidate Requirements:

·         Understanding of overall clinical trial processes

·         Experience with tools and systems used in executing clinical trials

·         Detail-oriented problem-solver with an analytical mindset

·         Ability to work effectively both independently and in teams

·         Comfortable collaborating with diverse backgrounds

·         Strong verbal and written communication skills

·         Interpersonal proficiency for effective communication across various organizational levels

·         Bachelor’s or University degree in medical or para-medical fields (or equivalent experience)

·         Minimum of 1 year of experience in Clinical Operations

·         Knowledge of ICH-GCP and relevant legislation for validated systems and quality processes

·         Experience with Veeva Vault, eTMF, CTMS, eDC, IRT, data analytics software (e.g., Tableau), etc., is advantageous

·         Biotech experience and experience in an outsourced model are beneficial.