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.

The Opportunity:

This position will be located in Alameda, California.

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

What you will do:

• 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.
• 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.
• 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 (± 10 years) in Business, Science, or equivalent academic field. An equivalent combination of education and work experience. Advanced degree is preferred.

Additional qualifications:

• 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 on time and on budget.
• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Proficient with Microsoft Suite.

The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.