Instagram
youtube
Facebook

Principal Clinical Contracts

2+ years
$95,500.00 – $190,900.00
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: MBA/BBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here is a summary of the Specialist Clinical Contracts position at Abbott:


Organization:

Abbott


Position Overview

Abbott is seeking a Specialist Clinical Contracts professional to assist with the clinical execution and management of contracts, budgets, accruals, and timelines for assigned clinical studies. This role ensures that clinical trial agreements are completed on time and in compliance with both internal and external regulations.


Key Responsibilities

  • Agreement Management: Populates, compiles, and verifies clinical trial agreements (such as Master Clinical Trial Site Agreements, Facility Use Agreements, and Statements of Work) to ensure timely clinical trial startup.
  • Negotiation and Coordination: Collaborates with Legal to negotiate and modify agreements and ensures that all documents meet regulatory, legal, and company guidelines.
  • Tracking & Compliance: Tracks accruals and study budgets, reviews and approves invoices, and ensures adherence to study financial plans.
  • Study Timelines: Plans, directs, and communicates timelines for clinical studies while overseeing operational aspects, ensuring quality delivery within the agreed budget and timeline.
  • Project Management: Coordinates the selection of clinical sites and vendors, manages priorities, and resolves issues, all while ensuring alignment with standard operating procedures (SOP), good clinical practice (GCP), and country-specific regulations.
  • Communication: Acts as the primary point of contact for negotiations with clinical trial sites and communicates financial metrics to appropriate business units.

Required Qualifications

  • Education: Bachelor’s Degree in Business, Science, or a related field (or an equivalent combination of education and work experience).
  • Clinical Trial Process Knowledge: Understanding of clinical trial processes, including study design, data management, and analysis.
  • Skills: Strong project management, organizational, and problem-solving skills; ability to manage multiple priorities.
  • Regulatory Knowledge: Familiarity with GCP, Clinical and Regulatory Affairs, and industry regulations (e.g., AvaMed Code of Ethics, US FDA regulations).
  • Experience: Experience with drafting contracts, negotiating budgets, and understanding general contract law.
  • Communication Skills: Strong written and verbal communication, interpersonal, and presentation skills.
  • Microsoft Suite Proficiency: Skilled in using Microsoft Office applications.
  • Travel Requirements: Ability to travel approximately 15%, including international travel.

Preferred Qualifications

  • Advanced Degree: Preferred, but not required.

Salary Range

  • Base Pay: $95,500.00 – $190,900.00 annually (may vary depending on location).

Benefits

  • Health Investment Plan (HIP) PPO: Free medical coverage for employees who complete a wellness assessment.
  • Retirement Savings Plan: High employer contribution.
  • Tuition Reimbursement: Available for career development.
  • Additional Benefits: Various benefits are provided to help employees live full lives.

Company Overview

Abbott is a global healthcare leader focused on improving lives through technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. The company serves over 160 countries and has 114,000 employees globally. Abbott is recognized for offering a great work environment, diversity, and opportunities for career growth.


Abbott offers a dynamic, fast-paced environment with opportunities for professional development in a global company committed to improving healthcare worldwide.