Senior Consultant, Clinical Operations

San Diego

 

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 Senior Consultant to join its Clinical Operations and Development practice area. As a Senior Consultant, Clinical Operations, you will independently manage multiple clinical programs for development stage biotech, pharmaceutical, and device companies to guide, develop, and advise on operational strategies.  You will develop and implement more advanced, complicated, and/or innovative strategies. You will appropriate delegate to and mentor junior level consultants to maximize your involvement across more projects. You may hold line management responsibilities and assume clinical leadership roles within client organizations.

Characteristic Duties:
  • Independently manage multiple clinical trials for biotech/pharma sponsor companies
  • Oversight of study managers across multiple studies
  • Establish project-related expectations, alignment of roles and responsibilities, and management of assigned projects to plan and budget
  • Lead development of protocol synopses, protocols, and ICFs; identify alternative study designs for efficiencies in cost/time
  • Develop accelerated yet feasible operational strategies to guide biotech and pharma companies thoughtfully through development 
  • Develop novel methodologies to carry out project objectives; establishes timelines, quality objectives and resource objectives
  • 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
  • Support clinical related process optimization initiatives and other Halloran practice area projects as a clinical subject matter expert
  • Opportunity for line management of internal Halloran resources
  • 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 a scientific discipline and a minimum of twelve years of related experience, including a minimum of eight years of trial management experience, and minimum of one year of direct line management responsibilities
  • Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  • Exercises judgment in selection methods, techniques and evaluation criteria for obtaining results
  • Networks with key contacts outside own area of expertise
  • Demonstrates independence in managing clients/deliverables with ability to proactively propose alternative solutions and pathways
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 opportunity.  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.

Halloran Consulting Group | Senior Consultant, Clinical Operations