Consultant, Clinical Operations

Boston - Remote within U.S. Option Available

 

Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!

Halloran is looking for a Consultant to join its Clinical Development & Operations practice area. As a Consultant, Clinical Operations, you will manage one or more clinical programs for development stage biotech, pharmaceutical, and medical device companies to guide, develop, and advice on operational plans.  You will collaborate with stakeholders to create and implement operational plans with minimal supervision or guidance for routine activities.

 

Characteristic Duties:

  • Independently manage one or more clinical trials for biotech/pharma sponsor companies
  • Establish project-related expectations, alignment of roles and responsibilities, and management of assigned projects to plan and budget
  • Support development of protocol synopses, protocols, and ICFs
  • Lead study planning activities including outlining operational strategies and assumptions to develop comprehensive timelines, budgets, study management plans, and risk mitigation plans based on GCP, regulatory guidelines, best clinical practice, and the competitive clinical landscape
  • Lead CRO/vendor selection processes, develop and manage vendor oversight plans, and manage CROs, vendors, and cross functional team members on behalf of clients
  • Independently manage all aspects of study management, development of study tools, training materials, recruitment plans, reports, timelines and other critical study deliverables
  • Proactively identify, mitigate, and raise awareness to project risks; ensure timely issue resolution
  • Provide ongoing updates to stakeholders via dashboards, presentations, and other appropriate communication methods
  • Scope client work & develop/manage client proposals/ SOWs
  • Support clinical related process optimization initiatives and other Halloran practice area projects as a clinical subject matter expert
  • Participate in internal activities such as publishing articles, presenting/moderating workshops, and attending conferences when opportunities arise
  • Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
  • Contribute to business development efforts, including the authoring of proposals for new client engagements and identifying business development opportunities in existing clients and educating clients on Halloran Services
  • Other duties and responsibilities as assigned

 

Qualifications:

Required:

  • Bachelor’s Degree in scientific discipline and a minimum of eight years of experience in clinical operations in a biotech or pharma setting, including at least four years leading project management and vendor oversight activities for clinical studies and CROs
  • Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors
  • Demonstrate good judgment in selection methods and techniques for obtaining solutions

 

Halloran Consulting Group, Inc. Perks:

  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Reimbursements for Health & Wellness Programs and Memberships
  • Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
  • Self-Managed PTO Policy
  • Commuter FSA Benefits

 

Notice:

Our company is committed to equal employment opportunities for all applicants and employees.  We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.

 

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

 

No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by a member of Halloran’s Human Resources or Talent Acquisition teams.

Halloran Consulting Group | Consultant, Clinical Operations