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Clinical Site Budget & Contract Specialist

Date:  Jan 28, 2023
Location: 

US

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

The Clinical Site Budget & Contract Specialist reports to the Manager, Global Clinical Site Budgets and is responsible for supporting the Clinical Programs team in accelerating the start-up, maintenance, and closeout activities of Abiomed’s clinical studies, primarily by supporting the development, negotiation and execution of site budgets and Clinical Trial Agreement amendments in North America.

 

 Principle Duties and Responsibilities:

  • Provide specialized study support and assistance to clinical teams in the preparation and development of master and country-level clinical site budget templates utilizing industry benchmarking to ensure fair market value pricing.  
  • Perform Clinical Trial Agreement budget review for compliance and/or modification to Abiomed standard template language utilizing departmental tools (e.g., Negotiation Guidelines/reference manual) to facilitate and streamline budget review timelines, with an aim to reduce escalation volume to internal teams.
  • Provide support to the development, negotiation, and execution of Clinical Trial Agreement amendments. Support will require collaboration with investigator sites, members of Clinical Operations management and the Office of General Counsel.
  • Preparation of study budgets projections for senior management for current and proposed studies.
  • Support the tracking and filing of your study support and documents internally using clinical systems (CTMS, eTMF, etc.)
  • Attend and support study team calls to align on status and identify risks to Site Initiation Visits (SIV) and site activation.
  • Assist Payments Coordinator with site payments/invoice process, as needed.
  • Other duties as assigned.

 Job Qualifications:

  • Bachelor’s degree in life sciences or related field required
  • Minimum of 3 years of clinical trial agreement and budgets experience in Clinical Trials at a Sponsor or Clinical Research Organization
  • Device Industry Experience preferred
  • Strong negotiation skills
  • Familiarity with budget development systems (i.e. - Grant Plan) and CMS billing practices preferred
  • Familiarity with clinical trial systems (CTMS, eTMF, EDC, etc)
  • Excellent understanding of ICH GCP
  • Creative, flexible and ability to think "out-of-the-box"
  • Proven success working collaboratively with diverse stakeholders across a global organization
  • Outstanding communication skills, verbal and written
  • Highly organized and detail-oriented
  • Ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment
  • Highly proficient in Microsoft Office Suite

#LI-Remote

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.