CARE

Study Start Up Manager

CARE

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $90,000 - $100,000 per year

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchstudy start-up activitiesGood Clinical Practiceproject managementprocess managementsite evaluationsite activationevidence-based decision makingscope of workproject plan
Soft Skills
written communicationverbal communicationinterpersonal skillsprofessionalismconfidentialitytime managementcollaborationrelationship buildingjudgmentprioritization