Clinical Development and Operations Coordinator

**The Position**: - The Clinical Development and Operations Coordinator manages key operational tasks, including non-trial vendor management, systems support, new employee orientation, GXP records archiving, meeting planning and oversight, and process improvement activities in Clinical Development & Operations (CD&O). They manage local non-trial related vendor set up in systems as well as supporting budgeting and payment activities for local vendors as needed. - The Clinical Development and Operations Coordinator ensures effective and efficient operations by leading trial agnostic process improvement activities including on-boarding, supporting crisis management activities, IT champion activities and CD&O communication.They play a pivotal role in coordinating communication within CD&O, creating and delivering content for monthly meetings, updating CD&O share point information and liaising with the corporate CD&O communication team. They drive regular activities in team building to support the optimal functioning of the CDO functional teams. **Responsibilities**: - **Process improvement**: - Implements process improvements to streamline and enhance clinical development and operations activities. - Establishes best practices for efficient on-boarding, harmonizing with global standards where appropriate. - Manages orientation for all new Clinical Development and Operations employees. - **Trial Agnostic Vendor Management**: - Serves as the primary vendor contact for all non-trial-related vendor activities. - Oversees non-trial vendor relationships and contracts, including hotels, media vendors, and special projects for local and global initiatives based out of Canada. - **Records Archiving**: - Monitors and drives the archiving of all GXP records within paper-based systems. - Ensures compliance with regulatory requirements and maintains organized, accessible records. - Supports inspection readiness activities as required - **Communication & Project Coordination**: - Acts as the primary communication liaison for Clinical Development and Operations in Canada. - Primary contact for external inquiries into CD&O such as medical information to triage requests - **Early asset support for priority programs** - Supports CD&O early asset core team to organize content, training and outputs for key assets. - Supports training initiatives for CD&O to optimize early customer engagement - **Meeting & Event Organization**: - Coordinates, plans, and organizes clinical development and operations meetings. - Serves as the main organizer for all internal team meetings, managing logistics including venue selection, attendee accommodation, on-site coordination, and support for technical and content needs. - Develops and assists with slide presentations and delivers updates during monthly meetings. - **IT Champion**: - Serves as the IT champion for the CD&O team, coordinating and managing any critical IT updates. - Presents and communicates IT mandates, efficiencies, and new proficiencies to the CD&O team. - Acts as the liaison between IT and the CD&O team ensuring alignment with technology-related objectives and addressing any function specific IT needs. This position is based in the Burlington, Ontario office located at 5180 South Service Road and is **flexible.** Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department. **Requirements**: - Bachelor's degree or >5 years' experience in Clinical Operations - **Communication**: - Strong Communication skills: Demonstrates strong communication in complex cross-functional matrix structures of CD&O functions. Communicates effectively to groups, varying style to fit the audience, actively communicating with those with differing opinions and differing levels of understanding. - **Problem Solving**: - Strong ability to prioritize and use creative thinking to resolve conflicting priorities. Defines problems, analyzes causes, identifies possible solutions, selects the best solution, and develops action plans. Uses innovative thinking to improve processes to go beyond traditional solutions. - **Project Management**: - Effectively prioritizes plans and timelines based on potential risk identification and monitors a course of action; recognizes the impact of tasks/risks to other team members. - **Accountability**: - Clearly defines mutual expectations of self and others. Takes appropriate actions to ensure obligations are met in a timely manner. Shows ownership for personal decisions and actions in all situations. Takes accountability for mistakes and is open to sharing lessons learned. Accepts accountability for team deliverables as appropriate - **Teamwork and Collaboration**: - Ability to establish and maintain effective relationships with internal and external customers in a manner that consistently meets the organization’s expectations. Ability to