Study Start Up Manager
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Job Description
Study Start Up Manager facilitating study start-up activities at Care Access. Leading cross-functional teams to activate clinical research studies efficiently.
Responsibilities:
- Care Access Study Start Up Managers play a critical role in 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)
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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