Care Access is hiring a
Study Start Up Manager

Summary

Join our team as a Senior Manager, SSU at Care Access, where you will play a critical role in facilitating study start-up activities, leading cross-functional groups, and ensuring quality. You will work closely with sites to prepare for evaluation visits, review study information, and track timelines. This is a remote position with less than 10% travel requirements.

Requirements

• Expert knowledge of general clinical research processes and Good Clinical Practice
• High level of professionalism and confidentiality required
• Excellent interpersonal skills
• Support with the development, implementation and maintenance of a robust study start-up process
• Support in driving continuous improvement initiatives in study start-up processes and systems to enhance efficiency and quality
• Ability to manage against tight timelines and competing priorities
• Excellent written and oral communication skills
• Strong judgment and ability to make evidence-based decisions
• Proficient with Microsoft Office Suite
• Experience working with Salesforce and CRIO
• Ability to work collaboratively across departments
• Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately
• Ability to build relationships effectively in a geographically dispersed, largely remote environment

Responsibilities

• Lead the process of global study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent
• Manage key clients and support with building key client portfolios
• Collect and interpret information from the Protocol & Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits
• Support sites through their evaluation and begin start-up activities upon selection
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Track and report on forecasted and actual SSU submission and approval timelines
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Work closely with the staff onsite to help address their remaining questions about the study & study activation requirements
• Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent
• Partner with other Care Access teams to initiate other Study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc)
• Partner and communicate with client to drive start-up activities, timelines and expectations of Care Access start-up process & sites
• Ensure that any and all information gained during the start-up process is completely transitioned to sites, as required
• Continue to assess and optimize study start up processes to enhance efficiency and productivity
• Monitor key performance indicators to track progress and identify areas of improvement
• Mentor and develop team members to enhance their skills and capabilities
• Implement Kanban methodology to improve workflow and task management
• Foster a culture of innovation and excellence within the start up team and support building strong relationships with the Site Network

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance