Care Access is revolutionizing clinical research by bridging the gap between patients, providers, and groundbreaking treatments. Founded with a mission to make clinical trials more
Study Start Up Manager
Location
United States
Posted
106 days ago
Salary
0
No structured requirement data.
Job Description
Study Start Up Manager
Care Access
This role involves facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements. 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 Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent 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
Job Requirements
- Minimum 3+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site
- Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)
- 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
Benefits
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
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