Study Start Up Manager

Summary

Join Care Access as a Study Start-Up Manager and play a critical role in facilitating the start-up activities needed to select and activate studies at various sites. You will support the selection and start-up process by leading cross-functional groups to complete pre-site visits and accelerate site activation, adhering to Care Access processes and industry regulations. This role involves managing communications with clients and site staff, overseeing site evaluations and initiation visits, and ensuring smooth transitions of information. You will also partner with internal teams to initiate study-related processes and manage vendor requirements. The position requires strong project management skills, excellent communication, and a minimum of 3 years of clinical research experience, including 1 year in study start-up activities. A bachelor's degree in life sciences or equivalent experience is preferred. This is a remote position with less than 10% travel.

Requirements

• Expert knowledge of general clinical research processes and Good Clinical Practice
• Excellent written and verbal communication skills
• High level of professionalism and confidentiality required
• Excellent interpersonal skills
• Ability to manage against tight timelines and competing priorities
• Strong judgment and ability to make evidence based decisions
• Proficient with Microsoft Office Suite
• 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
• Ability to independently coordinate and manage new processes
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Minimum 3+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site

Responsibilities

• Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits
• Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan
• Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent
• Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent
• 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
• Collect and review study activation requirements, understand startup timelines, key contacts & performance expectations
• Manage communications and expectations with client (Sponsor and/or CRO)
• Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team
• Manage communications and expectations with site staff
• Support sites through their evaluation and begin start-up activities upon selection
• Work closely with the staff onsite to help address their remaining questions about the study
• Ensure that any and all information gained during the start-up process is completely transitioned to sites and other central teams, as required
• 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)
• Liaise with internal key stakeholders across the organization to establish timelines and needs
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Both drive & support Care Access sites throughout the activation process, ensuring risk assessment, mitigation support and start up success
• Assist with triggering internal departments- such as (but not limited to) source, vendor management, operational compliance, etc
• Manage vendor requirements
• Start up escalation & mitigation
• Track and report on forecasted and actual SSU submission and approval timelines

Preferred Qualifications

Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)

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
• 401k retirement plan