Clinical Operations Processes and Systems Specialist

An amazing opportunity has opened within a leading clinical research organization who are looking to recruit an experienced Clinical Operations Processes and Systems Specialist who will act as the expert on clinical operation (CO) systems and associated processes. Collaborating with the Lead in CO Processes and Systems, this role assesses and promotes enhancements to business processes and systems, ensuring operational efficiency by implementing necessary changes or improvements. The Specialist also assists in documenting existing processes, systems, and enhancements, forecasting anticipated outcomes of process changes, and analyzing the impact of implemented changes.

Responsibilities:

·         Provide specialized end-user support and collaborate with Business Information Systems (BIS) and/or external vendors for escalated support needs (level 1-3).

·         Support readiness activities for inspections.

·         Evaluate current business processes and systems in Clinical Operations to identify areas for improvement or development, enhancing overall support to the business.

·         Analyze potential solutions to streamline processes and systems.

·         Review existing or new software applications in coordination with BIS through system demos and discussions.

·         Make informed business decisions regarding system implementation, modification, maintenance, etc.

·         Lead the conceptualization, development, and implementation of business processes and systems aligned with organizational objectives.

·         Act as the delegate for the System Business Owner in Computer System Validation (CSV), migration activities, and system access requests.

·         Drive the deployment of business processes and systems, providing ongoing support such as updating or creating relevant procedural documents, training, Q&A trackers, etc.

·         Act as the Business Administrator in the eTMF system, overseeing record maintenance and supporting close-out activities, including archival preparation. This includes various tasks like managing product records, picklist values, EDL Master Templates, ECO index, Document Templates, and metadata field updates.

·         Maintain comprehensive knowledge and adherence to ICH GCP guidelines and relevant regulations.

·         Propose initiatives for continuous improvements in business processes and systems.

·         Develop best practices for enhancing business processes and systems.

Candidate Requirements:

·         Proficiency in ICH-GCP and other applicable regulations to ensure quality processes and validated systems.

·         Strong understanding of clinical trial processes in their entirety.

·         Experience with tools and systems used for managing and executing clinical trials.

·         Strong project management and organizational skills.

·         Detail-oriented problem solver with a structured analytical approach.

·         Demonstrated leadership, critical thinking, and adept time management skills.

·         Ability to thrive in collaborative team environments and work autonomously when required.

·         Comfortable engaging with individuals from diverse backgrounds.

·         Effective verbal and written communication skills.

·         Interpersonal proficiency in communicating across various organizational levels.

·         Bachelor’s or University degree, preferably in medical or para-medical fields (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent experience.

·         Minimum of 3 years' experience in Clinical Operations.

·         Familiarity with Veeva Vault, eTMF, eDC, IRT, or data analytics and visualization software.

·         Bonus points for biotech experience and working in an outsourced model.