Manager, Global Clinical Site Budgets 6/4/2020
JOB DESCRIPTIONAPPLY 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, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed s 1,400 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 (Sr.) Manager, Global Clinical Site Budgets reports to the Associate Director, Clinical Programs 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 and execution of site budgets globally as well as developing comprehensive budget tools in support of Clinical Programs. Responsibilities may also include some Clinical Trial Agreement language negotiation and execution support, dependent upon resourcing.
Principle Duties and Responsibilities:
* Provide specialized study support and assistance to clinical teams in the preparation of study budgets utilizing Grant Plan and ensuring fair market value (FMV), as well as negotiation and execution of all global budgets for Clinical Trial Agreements and Amendments
* Perform Clinical Trial Site 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 and iterations including reduction of escalations to Clinical Program Managers
* Negotiate master budget rate cards with sites globally
* Collaborate with investigator sites and members of Clinical Operations Management to finalize/execute required budgets and contracts when requested
* Preparation, negotiation, and execution of Steering Committee (SC), Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) for all assigned studies in collaboration with Clinical Team stakeholders
* Preparation of study budgets projections for senior management for current and proposed studies
* As requested, assist with other site-related documents, such as amendments, addenda, facility use agreements, letters of indemnification, etc. under the direction of the Senior Manager, Clinical Site Contracts & Budgets and the Associate Director, Clinical Programs
* Bachelor s degree in life sciences required.
* 5 years of experience in Clinical Trials at a Sponsor or Clinical Research Organization
* Device Industry Experience preferred
* Familiarity with GrantPlan and CMS billing practices preferred
* 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
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.