Clinical Contract Associate II

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Position Summary

Works Independently on projects and assignments reporting progress to manager weekly. Creates, prepares, reviews and edits contracts, Master Agreements new work orders, amendments, modifications and change orders that are highly complex and high contract risk. Ensure contracts are in compliance with Company policies and in accordance with applicable regulations as well as maintaining the direction of Abbott's Legal Department, negotiate with research sites. Write technical contract language covering such items as indemnification, subject injury language, intellectual property rights, confidentiality, and other similar matters; together with negotiating fair and compliant budgets based on study protocol. Analyzes documents to determine corporate risk; prepares and provides alternative approaches to mitigate the risk. Seeks appropriate approvals from management for budget items in excess of department compliance policy with applicable justification documents. Performs final accuracy review of budget and contract documents and assist in the coordination of the signature process. Prepares appropriate contractual responses to meet applicable law and regulatory requirements. Networks with the Legal Team to assure compliance with laws and Abbott policy. Advises manager regarding potential issues. Identifies course of action and works in conjunction with management to implement. Should have a firm understanding of the clinical protocols, including study design, procedures to be performed at each visit, duration of trial, etc.

Main Responsibilities

Analyze and resolve differences in contract interpretations between Abbott and sites, and resolve conflicts as necessary

Works in conjunction with manager to ensure contractual requirements and timelines are met; ensures adherence to those timelines; communicates milestones and commitments.

Works on independent projects.

Advises manager regarding potential issues.

Creates, prepares, reviews and edits contracts, Master Agreements new work orders, amendments, modifications and change orders of a high complexity level and contract risk type. Analyzes documents to determine corporate risk; prepares and provides alternative approaches to mitigate the risk.

Solves unique and complex problems with broad impact on the business; requires conceptual and innovative thinking to develop solutions.

Maintain communication of negotiation status using Company IT systems.

Obtain necessary approvals for contractual documents by senior management.

Meet study site activation timelines utilizing effective negotiations skills which results in signed executable agreements

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

Bachelor's degree required. 2-5 years of related work experience

Contracting, Contracting Negotiations/Skill in redlining documents (Direct knowledge of Clinical Contracting preferred)

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