Senior Clinical Contracts Associate

Abbott•Plano, TX
•Onsite

About The Position

This position supports Abbott's medical devices clinical team. Abbott's medical device businesses offer technologies that are faster, more effective, and less invasive. The Senior Clinical Contracts Associate provides technical assistance in developing, negotiating, reviewing, and processing clinical study and research contracts and budgets. They understand key business drivers and corporate clinical priorities, using this understanding to accomplish their work. The role involves solving problems in straightforward situations, analyzing possible solutions using technical experience, judgment, and precedents. Impacts quality of own work and the work of others on the team, working within guidelines and policies. Capable of routine negotiations with little supervision. Under minimal guidance and supervision, develops and negotiates contracts, contract amendments, and complex budgets with site partners within expected timelines/metrics. Serves as a Business Unit champion/core team member/single point of contact for all study contract & budget-related activities throughout the study life cycle. Proactively collaborates with external/internal partners to address and resolve contract/budget issues to meet study milestones and deadlines. Reviews informed consents to ensure alignment with contract/agreement and provides guidance to study teams. Anticipates potential contract/budget compliance issues and implements timely risk mitigation.

Requirements

  • Bachelor's Degree (± 16 years) In Engineering, Biological Sciences, Nursing, or a related field strongly preferred OR an equivalent combination of education and work experience
  • Minimum 5 years In a clinical research environment or other equivalent experience preferred.
  • Knowledge of regulations and standards (Good Clinical Practices) for conducting clinical research.
  • Ability to travel domestically as needed
  • Polished communicator: written documentation and oral presentations/discussions/meetings
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail
  • Experience and training on GCP

Nice To Haves

  • Working knowledge of imaging modalities, including x-ray, fluoroscopy and MRI
  • Experience with GCP, ISO standards, and clinical trial guidelines
  • Masters Degree (± 18 years) In a relevant discipline/concentration.
  • Sponsor Pharma or Biotech experience preferred.
  • Direct knowledge of Sponsor Clinical Contracting preferred with direct experience in negotiating contract language & complex budgets
  • Budget Development experience
  • Advanced Excel experience
  • Experience with Power BI would be preferred

Responsibilities

  • Develop & negotiate contracts, contract amendments and complex budgets with site partners within expected timelines/metrics
  • Serve as a Business Unit champion/core team member/single point of contact for all study contract & budget-related activities throughout the study life cycle
  • Proactively collaborate with external/internal partners to address & resolve contract/budget issues to meet study milestones and deadlines
  • Review informed consents to ensure alignment with contract/agreement and provide guidance to study teams
  • Anticipate potential contract/budget compliance issues and timely risk mitigation

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
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