The Project Manager will work to support the aims of the Type 1 Diabetes TrialNet Clinical Network Hub, an NIDDK-funded grant in the Diabetes Clinical Research Program.
This position will serve on the Hub team working in partnership with the Hub Director and the Hub Program Manager to further the primary goals of the TrialNet Hub:
• Assuring that neither recruitment nor operations are limiting factors in TrialNet meeting its’ clinical objectives.
• Advancing systems and a culture that are sustainable and scalable, adaptable and forward thinking.
This position will be responsible for providing oversight and direction for improvement projects related to Clinical Site Operations including systems and processes related to clinical trials execution. This position will work closely with the TrialNet Coordinating Center’s staff including clinical research associates, statistical and programming staff and IT to identify and execute these operational initiatives.
• Collaborate with the Hub and the TrialNet Coordinating Center to identify operational strengths and areas for improvement, and develop process improvements to promote efficient and accurate conduct of clinical studies.
• Collaborate with the Hub Director and Hub Program Manager to develop outcomes and indicators that will be used to monitor the Hub’s progress towards its goals.
• Participate on the team, providing input on decision-making and strategic direction for the Hub
• Work collaboratively with cross-functional internal and external teams including TrialNet Data Coordinating Center, TrialNet Clinical Center staff—Principal Investigators and Research Coordinators.
• Identify any gaps in CRO SOPs and develop internal SOPs as needed.
• Be a part of the troubleshooting process to reach resolutions for any issues that arise during the course of a study.
• Manage and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team on related projects and efforts
• Assist with the development of presentations, handouts, and coordination of Steering Committee Meetings.
• Proactively monitor and provide regular updates to management team concerning status, metrics and progress of projects.
• Manage each project within agreed upon timelines.
• Perform other tasks as assigned.
• BS/BA degree required; advanced degree or BS/BA in science field preferred.
• The candidate should have a minimum of 3 years project management experience; clinical research and/or clinical project management experience preferred.
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
• Able to work in a team environment to operationalize and move projects forward
• Excellent written and oral communication and presentation skills.
• The candidate must demonstrate ability to manage multiple priorities, while maintaining attention to detail.
• Proficiency in Microsoft Office Suite is required; Tableau or data visualization software is preferred.
• Strong project management and organizational skills are required.
• Execute projects and ensure quality by working effectively with others and seeking direction as needed.
• Create and document policies and Standard Operating Procedures (SOPs) for clinical operations.
• Interact professionally in all conversations, correspondence and meetings. Willingness to prepare extensively as well as an ability to think critically and quickly on the spot, as well as the ability to project confidence and competence in public forums are necessary attributes.