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Clinical Site Budget & Contract Specialist - 00001J74DescriptionAbiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.I Am Abiomed | I Am Heart Recovery | Patients First!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.
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-RemoteAbiomed 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.Primary Location NA-United StatesOrganization Do not use (8535)Job Function Clinical Trial AdministrationReq ID: 00001J74
Vacancy expired!