Senior Clinical Systems Analyst 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 Senior Clinical Systems Analyst reports to the Associate Director, Clinical Programs and is responsible for supporting the implementation and maintenance of Clinical Systems for compliant and high quality clinical trial execution. In this position, you will focus on utilizing and optimizing clinical trial technology to increase efficiencies in clinical trial execution. You will work closely with Clinical Program Managers, Clinical Trial Coordinators and Clinical Data Managers to ensure compliant clinical trial systems to support clinical trials.
Principle Duties and Responsibilities:
* Collaborates with identified stakeholders to assist in development of organizational needs to develop process within Clinical Systems (EDC, CTMS, Imaging and eTMF) for better workflow
* Perform user acceptance testing of applications prior to implementation
* Identifies organizational needs, addresses any problems, and develops processes within Clinical Systems. Collaborates with related functional areas on organizational processes performed utilizing Clinical Systems
* Synthesizes data, information, and knowledge to clarify Clinical Systems issues or problems. Implements processes that streamline reporting within Clinical Systems
* Develops ideas, formulates, evaluates, and implements a plan for modifying Clinical System changes as needed, analyses multiple approaches/solutions for a specific issue or problem within Clinical Systems
* Optimizes Clinical Systems to function efficiently and effectively within Clinical Programs
* Develops and delivers training programs specific to Clinical Systems processes
* Collaborates with Vendors and Clinical Programs stakeholders as needed to ensure high quality compliant Clinical Systems and clinical system documentation
* Manages User Access Process across Clinical Systems including the development and maintenance of SOPs and Work Instructions
* Bachelor s degree in life sciences or information technology preferred
* 4 6 years of professional experience in clinical trials (Clinical Monitoring or Data Management preferred)
* 2-3 years of Medidata System platform (Cloud Administration, EDC, CTMS and Imaging) required
* 1-2 years of electronic Trial Master File experience required; Veeva Vault experience preferred
* Working knowledge of clinical trial operations required; Cardiology experience 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
* Strong presentation skills and technical audio-visual knowledge
* 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.