Principal Clinical Contracts

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

·         Career development with an international company where you can grow the career you dream of.

·         Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

·         An excellent retirement savings plan with 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.

·         A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

·         A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Specialist Clinical Contracts will assist in the clinical execution and management of contracts, budgets, accruals, and timelines aspects of assigned clinical studies.

What You'll Work On

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Populates, compiles, and verifies required agreements (based on templates approved and provided by Legal) to ensure timely clinical trial start and compliance to internal and external regulations.
• Negotiates Master Clinical Trial Site Agreements (“MCTSA”), Facility Use Agreements, Statements of Work and accompanying amendments, and assignments.
• Coordinates with Legal the modification and assembly of the agreements and documents referenced above.
• In conjunction with Legal department, ensures agreements and related documents are compliant to Legal, regulatory and company guidelines.
• Tracks, routes, and files Financial and regulatory documents in designated area.
• Track clinical studies’ accruals and spending to ensure adherence to study budgets and Funding approvals.
• Review and approve invoices related to ongoing clinical projects.
• Communicate clinical affairs accrual and spending and financial metrics to appropriate business entities. 
• Act as the primary contact within clinical Affairs for the negotiation of certain agreements and related documents with the clinical trial sites.
• Plans, directs, creates, and communicates clinical study timelines.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.
• Monitors progress and follows up with team members and line managers when issues develop.
• Ensures quality delivery of study deliverables within agreed budgets and timelines.

Required Qualifications

• Bachelor's Degree in Business, Science, or equivalent academic field. An equivalent combination of education and work experience
• Demonstrated understanding of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects