1+ months

Clinical Contract Associate II

Abbott
Plano, TX 75074
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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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 

Our location in Plano, TX or Sylmar, CA currently has an opportunity for a Clinical Contract Associate II. As a Clinical Contract Associate II, you’ll work without appreciable direction, provides technical assistance in negotiating, reviewing, and processing clinical study and research contracts and subcontracts in support of clinical research activities. This position will negotiate with research sites, ensure contracts are written in accordance to associated Business Unit and regulatory protocols, and obtain necessary approvals from senior management for research sites set-up. The work requires the application of business principles/methods, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year academic course of study.

WHAT YOU’LL DO

  • Perform a variety of activities involved in the drafting of contracts for clinical research
  • studies.
  • Monitor/review proposed contracts for compliance with applicable company policy as well as applicable regulations.
  • Write technical contract language covering such issues as indemnification, subject injury language, intellectual property rights, confidentiality, fiscal/procedural constraints, and other similar matters.
  • Maintain up-to-date Legal Department reference file.
  • Analyze and resolve technical problems of contract interpretation and resolves conflicts as necessary.
  • Participate in policy discussions and recommends policy or procedural changes as appropriate; revise and update procedures as necessary.
  • Work in conjunction with manager to ensure contractual requirements and timelines are met; ensure adherence to those timelines; communicate milestones and commitments.
  • 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.
  • Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met.
  • Ensure all clinical site contract comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
  • Identify issues/problems and provides customary recommendations for solutions. May focus on either contracts or grants or both areas based on Business Unite needs.
  • Work on diverse business problems that require financial analysis with oversight from more senior individuals in department. Assists clinical teams in resolving financial issues as they relate to site contracts.
  • Coordinate the preparation, execution, and tracking of domestic clinical site agreements, including study-specific budget templates, contracts and other documents with specific guidance from senior individuals.
  • Work closely with internal clinical teams to ensure rapid start-up of study sites. Be responsible for tracking the progress of study-start-up activities as it relates to contracts and budgets.
  • Be responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial.
  • Perform routine work under moderate supervision without detailed instructions and complex tasks under general supervision.
  • Collaborate with management to generate and track metric reports
  • Demonstrate moderate proficiency in the understand complex budgeting &  forecasting tools.
  • Interact well with clinical teams, legal, and payments team.
  • Advise manager regarding potential issues. Identify course of action and work in conjunction with management to implement.
  • Create, prepare, review and edit contracts, Master Agreements, statement of work , amendments, modifications and change contract changes  of a high complexity level and contract risk type. Analyze documents to determine corporate risk; prepare and provide alternative approaches to mitigate the risk.
  • Solve 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.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

    EDUCATION AND EXPERIENCE YOU’LL BRING

    Required

    • Bachelor's Degree in Business Administration, a related field, or equivalent.
    • Minimum of  6 years related work experience in Contracting, and 6 years Contracting Negotiations/Skills in redlining documents and analytical experience or equivalent.
    • Familiarity with grant and contract requirements, policies, and procedures including, but not limited to:
    • Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals.
    • Knowledge and understanding of GCP, ICH, GLP and other federal, state, industry rules and regulations governing technical aspects of clinical grants and contracts
    • Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
    • Requires a demonstrated knowledge of the practices/procedures of the function, company polices, and programs. 
    • Requires demonstrated 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.
    • Consistently demonstrated ability to understand and take effective approaches to varying levels of communication that would be most efficient and productive.
    • Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. 
    • Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks.  
    • Must have demonstrated personal computer skills including a working familiarity with relevant word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel and Access). Some evaluation, originality, and/or ingenuity required.

      Preferred

Posted: 2020-08-24 Expires: 2020-11-21

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Clinical Contract Associate II

Abbott
Plano, TX 75074

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