Principal Clinical Contracts

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

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 student debt program and 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 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.

Experience involving drafting terms and the negotiation of contracts and budgets, working knowledge of industry policies and procedures including but not limited to AvaMed Code of Ethics, applicable US FDA regulations as preferably clinical experience.

Demonstrates knowledge of federal state and industry rules and regulations governing technical aspects of budgets and contracts.

Demonstrates proficient knowledge of general contract law and principles. Requires comprehensive written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational and follow up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.

Experience working in a broader enterprise/cross-division business unit model preferred.

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 consistently meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Demonstrates strong interpersonal skills when working with internal and external customers as well as colleagues.

Ability to travel approximately 15%, including internationally.

Preferred Qualifications

Advanced degree is preferred.

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is $95,500.00 - $(phone number removed). In specific locations, the pay range may vary from the range posted.

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